Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FDC — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

97 daysmedian FDA review time

196 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K021166	ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR	Acmi-Circon Corporation	2002-05-09	28
K992141	OLYMPUS WORKING ELEMENT FOR PROBES	Olympus Winter & Ibe GmbH	1999-09-29	97
K991426	MAHE INSTRUMENTS	Mahe Intl., Inc.	1999-08-05	104
K942626	CONTINUOUS FLOW BIOPSY PROBE	Gm Engineering, Inc.	1995-05-30	362
K933962	GM CONTINUOUS FLOW BIOPSY PROBE	Gm Engineering, Inc.	1994-02-25	196
K895643	MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM	Orthoconcept, Inc.	1989-10-17	50
K894363	UROPUMP* FLUID MANAGEMENT SYSTEM	Orthoconcept, Inc.	1989-08-11	28
K842997	LASER RECTOSCOPE SET 784	Laser Industries , Ltd.	1984-08-27	28
K760184	ELEMENT, WORKING	V. Mueller O.V. Baxter Healthcare Corp.	1976-12-02	149
K760182	SHEATH, RESECTOSCOPE	V. Mueller O.V. Baxter Healthcare Corp.	1976-12-02	149
K760174	ADAPTER, RESECTOSCOPE	V. Mueller O.V. Baxter Healthcare Corp.	1976-08-30	55

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda