510(k) · Cleared
ClearedPeerbridge Cor (TM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peerbridge Health, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Sep 27, 2017 as substantially equivalent to K143513 (iRhythm Technologies, Inc., 2015) after a 91-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Sep 27, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963725 (1997). 27 ancestors in all, the oldest K881905 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 5 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 4 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 3 generations backK111438 REKA E100Reka Pte, Ltd. · 2011
- 2 generations backK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- 1 generation backK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- This deviceK171936 Peerbridge Cor (TM) SystemPeerbridge Health, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK253529 Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −6 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −5 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −4 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −3 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| −2 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| −1 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| 0 (this device) | K171936 | Peerbridge Cor (TM) System | Peerbridge Health, Inc. | 2017 | — |
| +1 | K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K143513 | ZIO SR ECG Monitoring ServiceSummary page 4…netic tape recorder PREDICATE DEVICE(S) [807.92(a)(3)] Primary Predicate: iRhythm Technologies, Inc. ZIO® SkyRunner Electrocardiogram Monitoring Services (K143513) (“SkyRunner”) Reference Devices: o GETEMED Medizin-und Informationstechnik AG, SEER 1000 (K130785… | 2015 |
| † | K130785 | SEER 1000 | 2013 |
| † | K071228 | Fidelity 200 Cardiac Event Recorder | 2007 |
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 |
|---|---|---|---|
| K253529 | Peerbridge COR MDx (Cor MDx) | 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 20 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K253529 (Peerbridge Health, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K143513.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Peerbridge Cor™ System family of products is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge Cor™ System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from…
Read the full statement (133 words)
The Peerbridge Cor™ System family of products is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge Cor™ System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.
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/K171936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171936: Peerbridge Cor (TM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171936
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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