510(k) · Cleared
ClearedSimplECG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanowear, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Nov 30, 2016 as substantially equivalent to K143032 (Mega Electronics, Ltd., 2015) and 1 other predicate after a 190-day review. Its family tree reaches back 7 generations to 1988. 5 later devices descend from it.
- Decided
- Nov 30, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K882803 (1988). 49 ancestors in all, the oldest K854030 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 6 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 5 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 4 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 3 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 2 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 1 generation backK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- This deviceK161431 SimplECGNanowear, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK232053 SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173248 CardioskinBioserenity Sas · 2018
Most influential descendants
Showing 5 of 5 · See all- K201669SimpleSENSENanowear, Inc. · 2020 · cites it directly3descendants
- K212160SimpleSENSE PlatformNanowear, Inc. · 2021 · 2 generations on1descendant
- K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025 · 2 generations on0descendants
- K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023 · 3 generations on0descendants
- K173248CardioskinBioserenity Sas · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −6 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −5 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −4 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −3 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −2 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −1 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| 0 (this device) | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +1 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +2 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +2 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
| +3 | K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023 | — |
| +1 | K173248 | Cardioskin | Bioserenity Sas | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K143032 | eMotion Faros ECG MobileSummary page 4…x Classification Name: 21CFR §870.2920 x Class II x Product Code DXH Predicate The predicate devices are: device(s) x K143032 eMotion Faros ECG Mobile cleared on March 29, 2015 from Mega Electronics Ltd. x K142476 Maste… | 2015 |
| * | K142476 | Master Caution Device MCDSummary page 4…The predicate devices are: device(s) x K143032 eMotion Faros ECG Mobile cleared on March 29, 2015 from Mega Electronics Ltd. x K142476 Master Caution Device cleared on February 17, 2015 from Healthwatch, Ltd. Based on a review… | 2015 |
What descends from it? (5)
2 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 28 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 49 ancestors have a recall of any class.
- Of its descendants, K201669 (Nanowear, Inc., 2020) has gone furthest, with 3 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. 2016, 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 SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the need for monitoring to manually assess their cardiac rhythm disturbance. ECG data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.
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/K161431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161431: SimplECG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161431
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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