FDA applicant

Protomed Corp.

Wayne, PA2 decisions1984–20200 recalls

FDA records 2 decisions for Protomed Corp. (Wayne, PA) from 1984 to 2020: 2 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and DZJ (Driver, Wire, And Bone Drill, Manual). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Protomed, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2020

2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Protomed Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?