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

FCL — Predicate Candidate Screening

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

76 daysmedian FDA review time

252 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032092	OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE	Olympus Optical Co., Ltd.	2003-07-16	9	0
K973611	SPECTRASCIENCE REUSABLE BIOPSY FORCEPS	Spectrascience, Inc.	1997-12-02	71	0
K971315	AUXILIARY INSTRUMENTS FOR URS	Richard Wolf Medical Instruments Corp.	1997-09-15	159	2
K964120	INJECTO FLUSH	Robert J. Jynch, Jr.	1996-12-30	76	0
K963517	SPECTRA SCIENCE BIOPSY FORCEPS	Spectrascience, Inc.	1996-12-02	90	0
K955065	OLYMPUS FB SERIES BIOPSY FORCEPS	Olympus America, Inc.	1996-01-24	79	0
K952863	FORCEPS, BIOPSY, NON-ELECTRIC	Annex Medical, Inc.	1995-07-19	27	0
K952391	DYNABITE UROLOGICAL FORCEPS	Portlyn Corp.	1995-06-01	10	0
K951048	RITE-BITE BIOPSY FORCEPS	Mill-Rose Laboratory	1995-03-15	9	0
K946360	MODULAR BIOPSY FORCEP	Cox Medical Ent., Inc.	1995-03-06	66	0
K950559	DIENER RETRIEVAL DEVICES	Mill-Rose Laboratory	1995-02-16	8	0
K946238	SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS	Symbiosis Corp.	1995-01-20	29	0
K944770	LSVP INTERNATIONAL BIOPSY FORCEPS	Lsvp Intl., Inc.	1994-10-13	16	0
K941816	EMC FLEXIBLE BIOPSY FORCEPS	Enterprise Medical Corp.	1994-07-13	91	0
K941359	GIP/MEDI-GLOBE BIOPSY FORCEPS	Medi-Globe Corp.	1994-07-12	113	0
K933135	DAWN DISPOSABLE BIOPSY FORCEPS	Dawn Medical	1994-03-07	252	0
K931957	SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS	Symbiosis Corp.	1994-02-28	314	0
K935070	GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS	KARL STORZ Endoscopy-America, Inc.	1994-01-25	92	0
K935250	ACCU-PATH	Cox Medical Ent., Inc.	1994-01-21	81	0
K934186	FORCEPS, BIOPSY, GASTROINTESTINAL	Primed Instruments, Inc.	1993-12-14	110	0
K925392	BIOPSY FORCEPS	Endo-Therapeutics, Inc.	1993-11-05	375	0
K932265	SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND	Symbiosis Corp.	1993-08-09	111	0
K922396	FUJINON FORCEPS -- MODIFICATION	Hobbs Medical, Inc.	1992-12-10	205	0
K914497	BIOPSY FORCEPS	Surgitek Medical Engineering Corp.	1992-01-03	87	0
K914212	BARD SINGULAR BIOPSY FORCEPS	C.R. Bard, Inc.	1991-11-27	69	0
K913883	COX DISPOSABLE BIOPSY FORCEP	Cox Medical Ent., Inc.	1991-10-05	37	0
K912549	BARD(R) DISPOSABLE BIOPSY FORCEPS	C.R. Bard, Inc.	1991-09-10	92	0
K912214	BARD SINGULAR BIOPSY FORCEPS	C.R. Bard, Inc.	1991-05-30	10	0
K896147	BIOPSY FORCEP (NON-ELECTRIC)	Portlyn Corp.	1990-04-16	175	0
K893636	GUARDIAN FORCEP	Endo-Scientific, Inc.	1990-04-09	332	0
K900065	NON-ELECTRIC BIOPSY FORCEPS	Esco Precision, Inc.	1990-03-15	70	0
K900015	NON-ELECTRIC BIOPSY FORCEPS	Esco Precision, Inc.	1990-03-15	72	0
K892252	BIOPSY FORCEPS	Zinnanti Surgical Instruments, Inc.	1989-10-03	182	0
K873176	HUFFMAN BIOPSY UNIT	Penn Medical Devices, Inc.	1987-10-14	63	0
K871710	BIOPSY FORCEPS	Frantz Medical Development, Ltd.	1987-08-10	101	0
K844551	HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT	Gobbs Medical, Inc.	1985-01-03	43	0
K844690	ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT	Jayco Pharmaceuticals	1985-01-02	30	0
K840818	BIOPSY FORCEPS	American Endoscopy, Inc.	1984-04-13	49	0
K800963	BIOPSY FORCEPS W/NEEDLE M.R. ASSOC.	Mr Associates, Inc.	1980-05-08	15	0

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