510(k) · Cleared
ClearedKardia Band System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AliveCor, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Nov 16, 2017 as substantially equivalent to K142743 (AliveCor, Inc., 2015) after a 150-day review. Its family tree reaches back 6 generations to 1997. 12 later devices descend from it.
- Decided
- Nov 16, 2017
- Review
- 150 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963725 (1997). 13 ancestors in all, the oldest K920984 (1992). 12 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 2 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 1 generation backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- This deviceK171816 Kardia Band SystemAliveCor, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK181823 KardiaAIAliveCor, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK183319 Triangle SystemAliveCor, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK182456 Study WatchVerily Life Sciences, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK192415 Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K181823KardiaAIAliveCor, Inc. · 2019 · cites it directly6descendants
- K183319Triangle SystemAliveCor, Inc. · 2019 · 2 generations on3descendants
- K182456Study WatchVerily Life Sciences, LLC · 2019 · cites it directly3descendants
- K210753KardiaMobile 6LAliveCor, Inc. · 2021 · 3 generations on2descendants
- K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −1 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| 0 (this device) | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| +1 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| +2 | K183319 | Triangle System | AliveCor, Inc. | 2019 | — |
| +1 | K182456 | Study Watch | Verily Life Sciences, LLC | 2019 | — |
| +3 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | — |
| +2 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K142743 | AliveCor Heart MonitorSummary page 4…tter and receiver Classification: 21 CFR§870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II Product Code: DXH, DPS PREDICATE DEVICE(S) x K142743 – AliveCor Heart Monitor (also known as Kardia Mobile)… | 2015 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K181823 (AliveCor, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K142743.
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. 2017, 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 Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
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/K171816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171816: Kardia Band System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171816
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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