510(k) · Cleared
ClearedTriangle 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 May 10, 2019 as substantially equivalent to K142672 (AliveCor, Inc., 2014) and 1 other predicate after a 161-day review. Its family tree reaches back 8 generations to 1997. 3 later devices descend from it.
- Decided
- May 10, 2019
- Review
- 161 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K963725 (1997). 21 ancestors in all, the oldest K920984 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 6 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 5 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 4 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 3 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 2 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 1 generation backK181823 KardiaAIAliveCor, Inc. · 2019
- This deviceK183319 Triangle SystemAliveCor, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK231424 HeartBeam AIMIGo (TM) SystemHeartbeam, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK220350 KardiaMobile 6LAliveCor, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −6 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −5 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −4 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −3 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −2 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| −1 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| 0 (this device) | K183319 | Triangle System | AliveCor, Inc. | 2019 | — |
| +1 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | — |
| +2 | K231424 | HeartBeam AIMIGo (TM) System | Heartbeam, Inc. | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K142672 | AliveCor Heart MonitorSummary page 5…K183319 510(k) SUMMARY Page 2 of 5 PREDICATE DEVICE(S) [807.92(a)(3)] K142672 – AliveCor Heart Monitor (currently marketed as “KardiaMobile”) K181823 – AliveCor KardiaAI DEVICE DESCRIPTION [807.92(a)(4)] Th… | 2014 |
| * | K181823 | KardiaAI Cleared while this submission was under review Summary page 5…Page 2 of 5 PREDICATE DEVICE(S) [807.92(a)(3)] K142672 – AliveCor Heart Monitor (currently marketed as “KardiaMobile”) K181823 – AliveCor KardiaAI DEVICE DESCRIPTION [807.92(a)(4)] The Triangle System is a trans-telephonic (transmission by smartphone) ele… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210753 | KardiaMobile 6L | 2021 | 2 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K210753 (AliveCor, Inc., 2021) has gone furthest, with 2 descendants of its own.
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. 2019, 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 Triangle System is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the…
Read the full statement (114 words)
The Triangle System is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The Triangle System 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 as stated in the FDA summary.
https://510kreport.com/device/K183319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183319: Triangle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183319
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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