510(k) Report

FDA applicant

Vocare, Inc.

Indianapolis, IN2 decisions2011–20210 recalls

FDA records 2 decisions for Vocare, Inc. (Indianapolis, IN) from 2011 to 2021: 2 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 5 predicates, 0 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 Vocare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12021: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Vocare, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 20213cite it

What has FDA decided for it lately?

  • K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc. · 2021
  • K111922Vocare Myhealth TabletVocare, Inc. · 2011

All 2 as Vocare, Inc. →