510(k) Report

FDA applicant

Safey Medical Devices Pvt, Ltd.

Pune, IN2 decisions2020–20200 recalls

FDA records 2 decisions for Safey Medical Devices Pvt, Ltd. (Pune, IN) in 2020: 2 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZH (Meter, Peak Flow, Spirometry). Its devices cite 2 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, anesthesiology panel, where it files most

How often FDA has decided Safey Medical Devices Pvt, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2020: 2
2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Safey Medical Devices Pvt, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZGSpirometer, Diagnostic1decision
  • BZHMeter, Peak Flow, Spirometry1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K201002Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd. · 2020
  • K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd. · 2020

All 2 as Safey Medical Devices Pvt, Ltd. →