FDA applicant

Drw Medical

Aston, PA2 decisions2018–20220 recalls

FDA records 2 decisions for Drw Medical (Aston, PA) from 2018 to 2022: 2 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and CAP (Monitor, Airway Pressure (Includes Gauge…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Drw Medical, LLC”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Drw Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Drw Medical by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Drw Medical

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?