510(k) · Cleared
ClearedStudy Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verily Life Sciences, LLC · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 19, 2022 as substantially equivalent to K192415 (Verily Life Sciences, LLC, 2020) after a 280-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Jul 19, 2022
- Review
- 280 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963725 (1997). 18 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations between
- 3 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 2 generations backK182456 Study WatchVerily Life Sciences, LLC · 2019
- 1 generation backK192415 Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020
- This deviceK213357 Study Watch with Irregular Pulse Monitor (Home), Study Watch with…Verily Life Sciences, LLC · 2022
Show all 9 generations
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 8 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 7 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 6 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 5 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 4 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 3 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 2 generations backK182456 Study WatchVerily Life Sciences, LLC · 2019
- 1 generation backK192415 Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020
- This deviceK213357 Study Watch with Irregular Pulse Monitor (Home), Study Watch with…Verily Life Sciences, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −8 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −7 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −6 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −5 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −4 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −3 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| −2 | K182456 | Study Watch | Verily Life Sciences, LLC | 2019 | — |
| −1 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020 | — |
| 0 (this device) | K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular… | Verily Life Sciences, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192415 | Study Watch with Irregular Pulse MonitorSummary page 4…er: 21 CFR 870.2920 Product Code: DXH, DPS Predicate Device: Study Watch with Irregular Pulse Monitor (K192415) Reason For Submission: Additional or Expanded Indications Interop… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 1 other device also cites its predicate K192415.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECQG) rhythms.
The Study Watch is intended for prescription use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213357: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026