Robot model
Apple Watch
Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared…
- Manufacturer
- Apple
- Form factor
- biometric
- Maturity
- commercial
- Lifecycle
- active
- Deployments
- 1
- Website
- apple.com ↗
The verified answer
As of Sep 2026, DEPLOY verifies Apple Watch, a biometric by Apple (commercial): 1 verified deployment on record. 9 sources back the record.
Apple Watch holds 2 FDA 510(k) clearances and 2 FDA De Novo authorizations and has 1 ITC exclusion order on record, per the DEPLOY registry.
See all 5 filingsOverview
Apple Watch (made by Apple Inc., Cupertino; current models the Series 11 and Ultra 3 from September 2025) is a biometric-primary smartwatch with FDA-cleared cardiac and sleep AI augmentation, sitting in the new biometric form factor distinct from the AI-primary wearable cohort because it would exist as a watch and biometric tracker without its AI layer, only degraded. Its FDA clearances are the verification anchor: the ECG app and Irregular Rhythm Notification were cleared via FDA De Novo in November 2018, AFib History via a 510(k) in June 2022 but only for users 22 and older already diagnosed with atrial fibrillation, sleep-apnea notifications via a 510(k) in September 2024 for moderate-to-severe obstructive sleep apnea in adults without an existing diagnosis and explicitly not for diagnosis, and hypertension notifications cleared in September 2025 as a 30-day passive screening tool rather than blood-pressure measurement.
Marketing that frames AFib History as detecting new atrial fibrillation, or the sleep-apnea and hypertension features as diagnostic or as blood-pressure monitoring, exceeds the cleared indications and is cap-flagged. The blood-oxygen feature is a load-bearing verified-versus-claimed exemplar: it was disabled on US units from January 17, 2024 after the Masimo International Trade Commission import ban, then re-enabled on August 14, 2025 through a redesign in which the watch sensor captures raw data but the oxygen value is computed on the paired iPhone and shown in the Health app, so the sensor capability never changed while the legal and computation pathway did.
Apple's clinical-validation posture is substantial, the highest peer-review volume in the cohort, anchored by the Stanford Apple Heart Study and large FDA submission studies, while the final Masimo legal end-state and whether the redesigned blood-oxygen reading matches the original accuracy are not verified.
Verified vs. claimed
- Maturity stage
- commercial(Commercially deployed with revenue-generating operations.)
- Sources on file
- View all sources →
Key facts
Form factor
FDA clearances
Sensor suite
Blood oxygen status
Subscription model
Price
Pricing model
Availability
Specs
Notes
Specs
Battery
Weight kg
Form Factor
Fda clearance
Data & sources
Press releases
1
News coverage
1
Government records
3
Research
1
Web sources
3
9 sources backing this record.View all →
Availability and pricing
- Availability
- Shipping now
- Price
- $399 to $799 (actual sale price)as of 2025-09-09
- Units in field
- Not disclosed
- Sales model
- Not disclosed
- Lead time
- Not disclosed
Pricing
Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.
Prices verified as of Sep 9, 2025
Deployments (1)
- Apple Watch at Globaloperational
Apple Watch aggregate global deployment.
Apple Watch on the deployment map
View the global mapWhere Apple Watch is verified operating. Explore the deployment map by place and type.
Recent activity
Every change to this record is dated, sourced, and independently verified where marked.
- Price point recordedJun 17, 2026
Not announced
- Specs.fda clearance verifiedVerifiedJun 7, 2026
cleared
- Verified media addedVerifiedJun 5, 2026
Apple Watch Crash Detection
- Verified media addedVerifiedJun 4, 2026
Health with iPhone + Apple Watch
- Record createdJun 3, 2026
Added to the verified registry
Deployment-verified media (2)
Apple's official how-to for Crash Detection on iPhone and Apple Watch. Crash Detection is a safety-sensor feature; it is distinct from Apple Watch's FDA-cleared health features (ECG, AFib history) and from its wellness metrics (activity rings, sleep stages), which are not medical-grade.
From deployment: Global
Apple's overview of health tracking with iPhone and Apple Watch. The ECG app and AFib History are FDA-cleared features; sleep and other metrics are wellness-grade.
From deployment: Global
Regulatory filings (5)
- K250507fda 510k · us_fdacleared2025-02-21
Applicant: Apple
- K240929fda 510k · us_fdacleared2024-04-04
Applicant: Apple
- 337-TA-1276itc exclusion order · us_itcactive2021-08-13
Applicant: Apple
- DEN180044fda de novo · us_fdagranted2018-08-14
Applicant: Apple
- DEN180044fda de novo · us_fdaactive2018-01-01
Applicant: Apple
Safety record
Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.
Incidents affecting Apple Watch (1)
- Apple disabled Blood Oxygen on US Apple Watch to comply with a Masimo ITC exclusion order2024-01-18 · Regulatory action
Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.
Sources (9)
- https://www.apple.com/newsroom/2018/12/ecg-app-and-irregular-heart-rhythm-notification-available-today-on-apple-watch/
- https://www.apple.com/newsroom/2025/08/an-update-on-blood-oxygen-for-apple-watch-in-the-us/
- https://www.cnbc.com/2024/09/16/fda-clears-apples-sleep-apnea-detection-feature-for-use-heres-how-it-works.html
- https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180044
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240929
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250507
- https://www.nejm.org/doi/full/10.1056/NEJMoa1901183
- https://www.apple.com/apple-watch-series-11/specs/
Compare Apple Watch
Common questions
What is Apple Watch?
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Can you buy Apple Watch?
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Is Apple Watch safe?
Apple Watch vs Oura Ring vs Whoop: which is best for health tracking?
Methodology: Verified · 9 sources (5 primary) · last reviewed 2026-07-15
Verification posture
Verified
High confidence
Review state
Stable
Last reviewed 2026-07-15
Maturity + lifecycle
Maturity stage: commercial
Lifecycle: active
Architectural position
Cohort: biometric
Sources by quality tier
- 3
- unclassified
- Unclassified source
- 3
- primary-fda-database
- FDA database
- 1
- secondary-established-publication
- Established publication
- 1
- primary-academic-peer-reviewed
- Peer-reviewed clinical / academic
- 1
- primary-company-ir
- Company IR disclosure
The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.
Methodology surface for Apple Watch.Recent coverage
Apple Watch in third-party press
Attention vs reality over time
Media mentions per month (area) against verified deployment events (dots). A press spike over a flat deployment line is the hype gap, drawn over time.
In the press
Recent coverage mentioning Apple Watch from third-party publications. Automatically surfaced; not part of the verified registry record.
The Apple Watch became an unlikely fashion icon by simply not being ugly
You could spend $17,00 on the first Apple Watch, but it turns out the device didn't need a limited edition gold case to become a fashion accessory. The post The Apple Watch became…
From the archive: Can Apple make the first wantable smartwatch?
From July 2015: Apple (with Tim Cook at the helm) had just announced the first version of Apple Watch and we tried to envision where it fit into the wearable landscape. The post…
Apple outlines ways to make devices easier to use as we age
Apple hit its 50th birthday this year, and many of its customers are even older. The company has created a new support page outlining 50 ways to make its devices easier to use,…
Pulse: Wiener Startup will Paare per Gesundheitsdaten besser verbinden
Wenn die Apple Watch am Handgelenk registriert, dass jemand schlecht geschlafen hat, bleibt diese Information normalerweise in einer Gesundheits-App liegen. Das Wiener Startup…
Pulse: Vienna Startup Wants to Bring Couples Closer Through Health Data
When an Apple Watch registers that its wearer slept badly, that information usually stays inside a health app. The Vienna startup Knightify FlexCo wants to turn it into something…
Apple prototyped a stylus for the foldable iPhone that we may never see
On the bright side, Apple is more certainly working on an Apple Watch overhaul.
Apple is testing continuous heart rate tracking for future Apple Watches
Apple is testing continuous heart rate monitoring for the Apple Watch, which could give it much richer fitness and wellness data throughout the day.
A redesigned Apple Watch now seems further in the future
Apple Watch Series 12 and Ultra 4 are expected to be modest upgrades, while Apple prepares a larger redesign with new health tracking and software.
John Ternus Management Team; Apple Watch Series 12; Foldable iPhone Apple Pencil
Also: Apple experimented with a Pencil for the coming foldable iPhone.
A Folding iPhone at Last? What to Expect From Apple’s Surprise and Shine Fall Event
From the iPhone 18 lineup to the Apple Watch 12 and new AirPods, this is everything Apple could release in its anticipated September event.
Everything we expect at Apples September iPhone launch event
What to expect from Apple's iPhone 18 launch: new Pro models, the first foldable iPhone Ultra, Apple Watches, and CEO Ternus.
See if you’re an Apple Watch person for just $89.99
This refurbished Apple Watch SE tracks workouts, heart rate, calls, texts, and more without the latest-model price. Get the 2020 smartwatch for $89.99.
Machine-readable surfaces
- Markdown mirror: /models/apple-watch.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/models/7af0d52f-fb71-4b04-88e9-413ec552cb52
- Revision history: /models/apple-watch/history
- Data documentation: /data
- Query this programmatically: Deploy MCP
Buyer-facing pricing: deploy.report/price/apple-watch
Video
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Apple has is planning to launch at least five new iPhone models through early 2027, according to Nikkei Asia. The company also has reportedly raised its foldabl
Reality vs attention
Apple Watch draws attention at the 98th percentile but verifies reality at the 18th percentile among biometric robots. Hype Gap +80.3, 1st widest among biometric robots.
6-month trend
Analysis
Strong recent media coverage and press activity. Thin deployment record; scale validation still in progress.
Signal flags
Dimension breakdown
Verified signal
Attention (reach, not merit)
DEPLOY Intelligence scores are computed from verified registry data: confirmed deployments, disclosed funding rounds, regulatory filings, active job listings, video viewership, and press coverage. Confidence ratings reflect data availability. Scores update nightly.
DEPLOY Indices — verified vs claimed
Last computed: Sep 2, 2026