510(k) Report

FDA applicant

Douglas Medical Products Corp.

Mundelein, IL20 decisions1992–20170 recalls

FDA records 20 decisions for Douglas Medical Products Corp. (Mundelein, IL) from 1992 to 2017: 20 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and HRX (Arthroscope). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Douglas Medical Products, Inc.”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Douglas Medical Products Corp.’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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Other applicant names beginning “Douglas”

FDA records each applicant name separately; these may or may not be the same firm.