510(k) · Cleared
ClearedPeerbridge COR MDx (Cor MDx)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peerbridge Health, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Sep 4, 2026 as substantially equivalent to K171936 (Peerbridge Health, Inc., 2017) after a 295-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Sep 4, 2026
- Review
- 295 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963725 (1997). 28 ancestors in all, the oldest K881905 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 6 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 5 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 4 generations backK111438 REKA E100Reka Pte, Ltd. · 2011
- 3 generations backK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- 2 generations backK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- 1 generation backK171936 Peerbridge Cor (TM) SystemPeerbridge Health, Inc. · 2017
- This deviceK253529 Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −6 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −5 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −4 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| −3 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| −2 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| −1 | K171936 | Peerbridge Cor (TM) System | Peerbridge Health, Inc. | 2017 | — |
| 0 (this device) | 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 |
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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K171936 | Peerbridge Cor (TM) SystemSummary page 5…MWJ Device Class Class II 3. Predicate Device Substantial equivalence is claimed to the Peerbridge Cor System (Cor 1.0), cleared under K171936. The predicate is a Class II device under 21 CFR 870.2800, product code DSH. The Cor MDx and the predicate share the same intende… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- None of the 28 ancestors has a recall.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder with a patient-activated event button, intended to record external ECG data for up to fourteen (14) days. It is indicated for use on adult patients eighteen (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. Recorded ECG…
Read the full statement (124 words)
The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder
with a patient-activated event button, intended to record external ECG data for up to fourteen
(14) days. It is indicated for use on adult patients eighteen (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. Recorded ECG data is
provided for manual retrospective review and interpretation by qualified clinical personnel
following the wear period.
The Cor MDx device does not perform automated arrhythmia detection, real-time analysis, or
diagnostic interpretation. The Cor MDx device itself is only intended for manual interpretation
and is not intended for ST segment analysis, ischemia detection, or myocardial infarction
detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253529: Peerbridge COR MDx (Cor MDx).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253529
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026