510(k) Report

FDA applicant

Obs Medical

Carmel, IN3 decisions2007–20110 recalls

FDA records 3 decisions for Obs Medical (Carmel, IN) from 2007 to 2011: 3 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 6 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 Obs Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12008: 12011: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K081140VisensiaObs Medical · 20083cite it
  • K110953Visensia, Visensia with AlertObs Medical · 20111cites it

What has FDA decided for it lately?

  • K110953Visensia, Visensia with AlertObs Medical · 2011
  • K081140VisensiaObs Medical · 2008
  • K071606Biosign Central StationObs Medical · 2007

All 3 as Obs Medical →