510(k) Report

FDA applicant

Peerbridge Health, Inc.

New York, NY2 decisions2017–20260 recalls

FDA records 2 decisions for Peerbridge Health, Inc. (New York, NY) from 2017 to 2026: 2 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and MWJ (Electrocardiograph, Ambulatory (Without…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Peerbridge Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Peerbridge Health, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSHRecorder, Magnetic Tape, Medical1decision
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc. · 20171cites it

What has FDA decided for it lately?

  • K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc. · 2026
  • K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc. · 2017

All 2 as Peerbridge Health, Inc. →