510(k) Report

FDA applicant

Proto-Med, Inc.

Mchenry, IL4 decisions1981–19840 recalls

FDA records 4 decisions for Proto-Med, Inc. (Mchenry, IL) from 1981 to 1984: 4 510(k) clearances. Most are in product codes HHF (Remover, Intrauterine Device, Contraceptive…) and CAW (Generator, Oxygen, Portable). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Proto-Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Proto-Med, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Proto-Med, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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