510(k) · Cleared
ClearedLifeLens Wireless ECG Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LifeLens Technologies, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Jul 20, 2021 as substantially equivalent to K163535 (Dms-Service, LLC, 2017) after a 270-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Jul 20, 2021
- Review
- 270 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950944 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 5 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 4 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 3 generations backK131190 MypatchDms-Service, LLC · 2013
- 2 generations backK160704 myPatch-sDms-Service, LLC · 2016
- 1 generation backK163535 my Patch slDms-Service, LLC · 2017
- This deviceK203168 LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260157 LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −5 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −4 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −3 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −2 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| −1 | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| 0 (this device) | K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | 2021 | — |
| +1 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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 |
|---|---|---|---|
| * | K163535 | my Patch slSummary page 4…y Predicate Devices Manufacturer Device Name K Number Dms-Service, LLC myPatch®-sl K163535 Indications for Use: LifeLens Wireless ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer f… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260157 | LifeLens Physiological Monitor | 2026 | 0 |
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 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K260157 (LifeLens Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K163535.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
LifeLens Wireless ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The LifeLens Wireless ECG Monitor is intended for use by patients 18 years or older. The LifeLens Wireless ECG Monitor is not intended to be worn during defibrillation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203168: LifeLens Wireless ECG Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203168
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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