510(k) · Cleared
ClearedKardiaMobile 6L
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 May 25, 2022 as substantially equivalent to K210753 (AliveCor, Inc., 2021) after a 107-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- May 25, 2022
- Review
- 107 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K963725 (1997). 23 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 10 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations between
- 3 generations backK181823 KardiaAIAliveCor, Inc. · 2019
- 2 generations backK183319 Triangle SystemAliveCor, Inc. · 2019
- 1 generation backK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- This deviceK220350 KardiaMobile 6LAliveCor, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 9 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 8 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 7 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 6 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 5 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 4 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 3 generations backK181823 KardiaAIAliveCor, Inc. · 2019
- 2 generations backK183319 Triangle SystemAliveCor, Inc. · 2019
- 1 generation backK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- This deviceK220350 KardiaMobile 6LAliveCor, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −9 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −8 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −7 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −6 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −5 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −4 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| −3 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| −2 | K183319 | Triangle System | AliveCor, Inc. | 2019 | — |
| −1 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | — |
| 0 (this device) | K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K210753 | KardiaMobile 6LSummary page 4…Class II Product Code DXH Subsequent Product Code DPS, QDA Predicate Information [807.92(a)(3)] Predicate(s) AliveCor, Inc., K210753, KardiaMobile 6L Device Description [807.92(a)(4)] KardiaMobile 6L is a trans-telephonic (transmission by smartphone) electrocar… | 2021 |
| † | K183319 | Triangle System | 2019 |
| † | K181823 | KardiaAI | 2019 |
| † | K201985 | KardiaAI | 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 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K210753.
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?
KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) thythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-1II and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAl platform including detecting the presence of…
Read the full statement (109 words)
KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) thythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-1II and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAl platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. KardiaMobile 6L is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.
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/K220350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220350: KardiaMobile 6L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220350
Report an extraction error
Are you the manufacturer?
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