510(k) Report

FDA applicant

Physician Engineered Products, Inc.

Park Rapids, MN8 decisions1985–20121 recall

FDA records 8 decisions for Physician Engineered Products, Inc. (Park Rapids, MN) from 1985 to 2012: 8 510(k) clearances. Most are in product codes LBI (Unit, Neonatal Phototherapy) and FMS (Bed, Pediatric Open Hospital). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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, general hospital panel, where it files most

How often FDA has decided Physician Engineered Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Physician Engineered Products, 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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Other applicant names beginning “Physician”

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