510(k) Report

510(k) · Cleared

Cleared

ePatch

K171410510(k) TraditionalCleared Jan 4, 2018234-day reviewClass II21 CFR 870.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Braemar Manufacturing, LLC · DSH Recorder, Magnetic Tape, Medical

Cleared on Jan 4, 2018 as substantially equivalent to K160704 (Dms-Service, LLC, 2016) and 1 other predicate after a 234-day review. Its family tree reaches back 5 generations to 1996. 7 later devices descend from it.

Decided
Jan 4, 2018
Review
234 days
Class
Class II
Product code
DSH
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K950944 (1996). 7 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2009: 1 other ancestor2023: 1 descendant cleared2022: 2 descendants cleared2026: 2 descendants cleared2024: 2 descendants clearedK950944 · Ambulatory (Holter) Recording System · Biosensor Corp. · 1996K993618 · DXP1000 Holter Recorder · Braemar Corp. · 1999K113176 · Mysense Heart · Cardiac Science Corporation · 2011K131190 · Mypatch · Dms-Service, LLC · 2013K160704 · myPatch-s · Dms-Service, LLC · 20161995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants K160704 · myPatch-s · Dms-Service, LLC · 2016K131190 · Mypatch · Dms-Service, LLC · 2013K113176 · Mysense Heart · Cardiac Science Corporation · 2011K993618 · DXP1000 Holter Recorder · Braemar Corp. · 1999K950944 · Ambulatory (Holter) Recording System · Biosensor Corp. · 1996−50
  1. Root · 5 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
  2. 4 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
  3. 3 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
  4. 2 generations backK131190 MypatchDms-Service, LLC · 2013
  5. 1 generation backK160704 myPatch-sDms-Service, LLC · 2016
  6. This deviceK171410 ePatchBraemar Manufacturing, LLC · 2018
  7. Descendant · cites it directly · 3 of its ownK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
  8. Descendant · cites it directly · 2 of its ownK211709 BiotresBiotricity · 2022
  9. Descendant · 2 generations on · 0 of its ownK253384 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M…Seers Technology Co., Ltd. · 2026
  10. Descendant · cites it directly · 0 of its ownK252389 Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
  11. Descendant · 2 generations on · 0 of its ownK233864 ASSURE Wearable ECGKestra Medical Technologies, Inc. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2022: 22023: 12024: 22026: 2
2022high 2 (2022) · low 0 (2025)2026

Most influential descendants

Showing 5 of 7 · See all
  • K231289S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023 · cites it directly3descendants
  • K211709BiotresBiotricity · 2022 · cites it directly2descendants
  • K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd. · 2026 · 2 generations on0descendants
  • K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026 · cites it directly0descendants
  • K233864ASSURE Wearable ECGKestra Medical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K950944Ambulatory (Holter) Recording SystemBiosensor Corp.1996—
−4K993618DXP1000 Holter RecorderBraemar Corp.1999—
−3K113176Mysense HeartCardiac Science Corporation2011—
−2K131190MypatchDms-Service, LLC2013—
−1K160704myPatch-sDms-Service, LLC2016—
0 (this device)K171410ePatchBraemar Manufacturing, LLC2018—
+1K231289S-Patch Ex Wearable ECG PatchWellysis Corp.2023—
+1K211709BiotresBiotricity2022—
+2K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML…Seers Technology Co., Ltd.2026—
+1K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.2026—
+2K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
202310
202420
202620
FIG. 1 — Lineage of K171410, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K160704myPatch-s
Summary page 4
…e: DSH Trade / Common Name: ePatch® 3. PREDICATE DEVICES Primary Predicate: DMS Service LLC myPatch®s- subject of K160704 Secondary Predicate: DMS Service LLC myPatch® Ambulatory ECG Recorder- subject of K131190 Braemar Manufacturi…
Dms-Service, LLC2016—
*K131190Mypatch
Summary page 4
…rimary Predicate: DMS Service LLC myPatch®s- subject of K160704 Secondary Predicate: DMS Service LLC myPatch® Ambulatory ECG Recorder- subject of K131190 Braemar Manufacturing Traditional 510(k) ePatch Page 1 of 8…
Dms-Service, LLC2013—

Also cleared against K160704: 1 other device →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K231289S-Patch Ex Wearable ECG PatchWellysis Corp.20233
K211709BiotresBiotricity20222
K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.20260

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 5 companies; a new generation was cleared every 2.7 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K231289 (Wellysis Corp., 2023) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K160704.

How does its category compare?

All DSH devices

DSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · DSH

4in 2025

2007: 12008: 12009: 32010: 22011: 62012: 22013: 22014: 12015: 22016: 22017: 32018: 32019: 32020: 42021: 42022: 42023: 62024: 22025: 42026 (partial year): 2
2007high 6 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSH

205in 2025

2009: 84 days median2011: 64 days median2017: 91 days median2018: 269 days median2019: 30 days median2020: 122 days median2021: 263 days median2022: 427 days median2023: 198 days median2025: 205 days median
2007high 427 (2022) · low 30 (2019)2026

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

2009: 12010: 82011: 32012: 12013: 22014: 32015: 82016: 62017: 312018: 302019: 762020: 912021: 1132022: 462023: 652024: 882025: 213
2007high 213 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
200938401
20102—08
201166403
20122—01
20132—02
20141—03
20152—08
20162—06
2017391031
20183269030
2019330076
20204122091
202142630113
20224427046
20236198065
20242—088
202542050213
20262—0—

What is it indicated for?

The ePatch® 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 ePatch® is intended for use by adolescents 18-21 and adults.

Indications for use as stated in the FDA summary.

Also cleared against K160704

1 other device cites the same predicate.

  • K163535my Patch slDms-Service, LLC · 2017

More from Braemar Manufacturing, LLC

3 FDA decisions under this applicant name. See the company

  • K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC · 2016
  • K130294Braemar Cardiokey Holter RecorderBraemar Manufacturing, LLC · 2013

Recent decisions in DSH

The DSH category page

  • K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
  • K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
  • K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025
  • K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc. · 2025
  • K243603AeviceMDAevice Health Pte., Ltd. · 2025

https://510kreport.com/device/K171410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171410: ePatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171410

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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