510(k) Report

FDA applicant

Del Mar Reynolds Medical, Ltd.

Hasbrouck Heights, NJ5 decisions2004–20071 recall

FDA records 5 decisions for Del Mar Reynolds Medical, Ltd. (Hasbrouck Heights, NJ) from 2004 to 2007: 5 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DPS (Electrocardiograph). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Del Mar Reynolds Medical, Inc.”.

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 Del Mar Reynolds Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Del Mar Reynolds Medical, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Del Mar Reynolds Medical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone2decisions
  • DPSElectrocardiograph2decisions
  • MNRVentilatory Effort Recorder1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 20054cite it
  • K051960Cardionavigator +Del Mar Reynolds Medical, Ltd. · 20051cites it
  • K062397SentinelDel Mar Reynolds Medical, Ltd. · 20071cites it

What has FDA decided for it lately?

  • K062397SentinelDel Mar Reynolds Medical, Ltd. · 2007
  • K062469Voyager 12Del Mar Reynolds Medical, Ltd. · 2006
  • K051960Cardionavigator +Del Mar Reynolds Medical, Ltd. · 2005
  • K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 20051 recall
  • K040313HRV ToolsDel Mar Reynolds Medical, Ltd. · 2004

All 4 as Del Mar Reynolds Medical, Ltd. →The one decision as Del Mar Reynolds Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042745Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is…Nov 11, 2011