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

FGO — Predicate Candidate Screening

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

163 daysmedian FDA review time

269 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K001563	SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET	Scion Cardiovascular, Inc.	2000-11-22	187	2
K970121	STONE DISLODGER, BASKET	Boston Scientific Corp	1997-04-02	78	0
K963750	RETRIEVAL SNARE	Boston Scientific Corp	1996-11-22	65	0
K962676	DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE	United States Endoscopy Group, Inc.	1996-10-04	87	2
K951309	STONE DISLODGER, BASKET	Boston Scientific Corp	1995-05-17	56	0
K933261	GRASPING FORCEPS	Surgitek	1994-01-11	189	0
K934598	GRASPING FORCEPS OR RETRIEVAL FORCEPS	Annex Medical, Inc.	1994-01-07	105	0
K921295	INTRAVENOUS CATHETERS MODIFICATIONS	Critikon Company, LLC	1993-05-17	431	0
K922542	GRASPING FORCEPS	Surgitek	1992-08-19	82	0
K914112	METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE	Annex Medical, Inc.	1992-02-28	168	0
K914111	METAL URETERAL BASKET STONE DISLODGER, HELICAL	Annex Medical, Inc.	1992-02-28	168	0
K914110	GRASPING FORCEPS	Annex Medical, Inc.	1992-02-28	168	0
K896322	CN GAURD, STERILE LATEX SURGICAL GLOVES	C.N. Technocrats	1990-07-12	253	0
K895080	SURGICAL GLOVES	Jet Far Industries, Inc.	1990-01-24	163	0
K893522	SURGEON'S GLOVES	Thai Fuji Latex Co., Ltd.	1990-01-22	259	0
K885168	RUBENSTEIN URETERAL STONE FRAGMENT BRUSH	Boston Scientific Corp	1989-09-08	269	0
K891252	UROLOGICAL LOOP RETRIEVERS	Northgate Research, Inc.	1989-03-22	14	0
K891253	UROLOGICAL GRASPING FORCEPS	Northgate Research, Inc.	1989-03-22	14	0
K771302	PFISTER-SCHWARTZ STONE RETRIEVER	V. Mueller O.V. Baxter Healthcare Corp.	1977-08-02	18	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