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

GCM — Predicate Candidate Screening

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

111 daysmedian FDA review time

481 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K203226	TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM /	Richard Wolf Medical Instruments Corporation	2021-05-14	193
K083840	MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE	Msi Medserv International Deutschland GmbH	2009-09-28	278
K001217	INSIDE VIEW	Monadnock Optics, Inc.	2000-07-11	85
K993103	ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETE	Richard Wolf Medical Instruments Corp.	1999-12-10	85
K993445	OMNISONIC ENDOSCOPIC DEFLECTOR	Omnisonics Medical Technologies	1999-12-06	55
K962393	KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION	KARL STORZ Endoscopy-America, Inc.	1996-09-17	89
K950712	PORTABLE ENDOSCOPY SYSTEM	Laser-Optik-Systeme GmbH & Co. KG	1996-05-14	455
K955120	HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR	Ethicon Endo-Surgery, Inc.	1996-01-26	78
K935235	ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY	Smith & Nephew Richards, Inc.	1995-03-23	507
K945889	KARL STORZ PLASTIC SURGERY ACCESSORIES	KARL STORZ Endoscopy-America, Inc.	1995-03-22	111
K931954	THORACOSCOPE/LAPAROSCOPE	Surgical Technologies, Inc.	1993-11-02	196
K921918	FIBER OPTIC ENDOSCOPE	Electro Fiberoptics Corp.	1993-08-17	481
K925918	PRESSURE TURING AND ACCESSORIES	Applied Medical Resources	1993-02-12	81
K921883	ENDOSCOPE	Optimed Technologies, Inc.	1992-11-23	216
K901464	MEDILASE SERIES 2200 ENDOSCOPE	Medical Laser, Inc.	1990-08-07	132
K894592	LAMANO DIRECTORS	Marlo Surgical Technology	1989-09-08	46
K853514	RIGID ENDOSCOPE	American Edwards Laboratories	1985-10-04	43
K844769	RIGID FIBEROPITC ENDOSCOPE	Microvasive	1985-01-15	39

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