510(k) · Cleared
ClearedHeartrak Smart Ecat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Medical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Dec 15, 2008 as substantially equivalent to K071130 (Universal Medical, Inc., 2008) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1997. 17 later devices descend from it.
- Decided
- Dec 15, 2008
- Review
- 17 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963725 (1997). 11 ancestors in all, the oldest K960499 (1996). 17 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 1 generation backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- This deviceK083535 Heartrak Smart EcatUniversal Medical, Inc. · 2008
- Descendant · cites it directly · 16 of its ownK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK141813 Rhythmstar SystemRhythMedix, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK143032 eMotion Faros ECG MobileMega Electronics, Ltd. · 2015
- Descendant · 3 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 4 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K131699Emotion Ecg MobileMega Electronics, Ltd. · 2013 · cites it directly16descendants
- K141813Rhythmstar SystemRhythMedix, LLC · 2014 · cites it directly8descendants
- K143032eMotion Faros ECG MobileMega Electronics, Ltd. · 2015 · 2 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 3 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −1 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| 0 (this device) | K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | 2008 | — |
| +1 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| +1 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
| +2 | K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | 2015 | — |
| +3 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +4 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071130 | Heartrak AFSummary page 2…Classification Product Number Name _________Name Code K071130 Heartrak Smart Universal Medical, transmitters and DXH AF… | 2008 |
| * | K060911 | CG-6108 Arrhythmia Ecg Event RecorderSummary page 2…iograph, ____ ___ ____ _____ ___ ____ ____ ___ telephone 870.2920 K060911I Cg-61 08 Card Guard Scientific transmitters and DXH… | 2006 |
What descends from it? (17)
See all 172 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 11 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K131699 (Mega Electronics, Ltd., 2013) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K071130.
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. 2008, 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?
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of a compatible RF receiver, uploads recorded ECG waveform and ECG parameter…
Read the full statement (110 words)
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of a compatible RF receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083535: Heartrak Smart Ecat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083535
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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