510(k) · Cleared
ClearedSimpleSENSE
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 6, 2020 as substantially equivalent to K161431 (Nanowear, Inc., 2016) after a 140-day review. Its family tree reaches back 8 generations to 1988. 3 later devices descend from it.
- Decided
- Nov 6, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K882803 (1988). 50 ancestors in all, the oldest K854030 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 7 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 6 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 5 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 4 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 3 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 2 generations backK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- 1 generation backK161431 SimplECGNanowear, Inc. · 2016
- This deviceK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK212160 SimpleSENSE PlatformNanowear, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK243981 Hexoskin Medical System (7100-00016)Carre Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK232053 SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc. · 2023
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 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −7 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −6 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −5 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −4 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −3 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −2 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| −1 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| 0 (this device) | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +1 | K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021 | — |
| +1 | K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025 | — |
| +2 | K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K161431 | SimplECGSummary page 4…raph §870.1875 DQD 2 Stethoscope, Electronic Predicate The predicate device is: devices • K161431 SimplECG cleared on 11/30/2016 from Nanowear, Inc. The following devices are considered as reference devices:… | 2016 |
| † | K160981 | Patient Monitor | 2016 |
| † | K151319 | Eko Electronic Stethoscope System | 2015 |
What descends from it? (3)
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 32 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 50 ancestors have a recall of any class.
- Of its descendants, K212160 (Nanowear, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K161431.
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. 2020, 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 SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as…
Read the full statement (154 words)
The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201669: SimpleSENSE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201669
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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