510(k) Report

FDA applicant

Biologic Therapies, Inc.

Prior Lake, MN1 decision2015–20152 recalls

FDA records 1 decision for Biologic Therapies, Inc. (Prior Lake, MN) in 2015: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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 Biologic Therapies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Biologic Therapies, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Biologic”

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