Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GDY — Predicate Candidate Screening

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

53 daysmedian FDA review time

126 days90th percentile

111clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972634	ULTRACELL SUCTION SPONGE	Ultracell Medical Technologies, Inc.	1997-12-17	156	0
K960236	CPR LAP SPONGES	Custom Pack Reliability	1996-03-28	72	0
K955599	STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE	Stryker Corp.	1996-02-22	76	5
K955322	PROTEC X-RAY DETECTABLE GAUZE SPONGE	Derivados DE Gasa, S.A. DE C.V.	1995-12-19	29	0
K953830	KENSORB	Kentron Health Care, Inc.	1995-10-03	48	0
K953060	ROSEBUD DISSECTOR	Medical Perspectives Corp.	1995-09-14	76	0
K953087	CHERRY PIT DISSECTOR	Medical Perspectives Corp.	1995-09-14	73	0
K953057	CYLINDRICAL SPONGE	Medical Perspectives Corp.	1995-09-14	76	0
K953058	ROUND STICK SPONGES, FLAT STICK SPONGES	Medical Perspectives Corp.	1995-09-14	76	0
K953088	TRIANGULAR SPONGES	Medical Perspectives Corp.	1995-09-14	73	0
K953059	KITTNER DISSECTOR	Medical Perspectives Corp.	1995-09-14	76	0
K953062	CHERRY DISSECTOR	Medical Perspectives Corp.	1995-09-14	76	0
K951911	GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)	Commercial Resources New Mexico, Ltd.	1995-06-21	58	0
K950372	ULTRACELL ORTHOPEDIC SPONGES	Ultracell Medical Technologies, Inc.	1995-04-17	76	0
K950370	ULTRACELL ORTHOPEDIC SPONGES	Ultracell Medical Technologies, Inc.	1995-04-17	76	0
K950373	ULTRACELL ORTHOPEDIC SPONGES	Ultracell Medical Technologies, Inc.	1995-04-17	76	0
K950659	ULTRACELL RETRACTOR COVERS	Ultracell Medical Technologies, Inc.	1995-04-13	59	0
K945335	CHERRY DISSECTOR	Lorrex Health Products	1994-12-28	57	0
K945866	CYLINDRICAL SPONGE	Lorrex Health Products	1994-12-28	27	0
K945606	TRIANGULAR SPONGES	Lorrex Health Products	1994-12-28	43	0
K945553	ROUND STICK SPONGES, FLAT STICK SPONGES	Lorrex Health Products	1994-12-28	48	0
K945333	KITTNER DISSECTOR	Lorrex Health Products	1994-12-28	57	0
K944879	GAUZE SPONGES	Clinical Resources, Inc.	1994-12-23	81	0
K940764	OREX	Thantex Specialties, Inc.	1994-12-19	304	0
K940767	OREX (12X12 X-RAY DETECTABLE)	Thantex Specialties, Inc.	1994-12-19	304	0
K940766	OREX (18X18 X-RAY DETECTABLE)	Thantex Specialties, Inc.	1994-12-19	304	0
K945336	PEANUT DISSECTOR	Lorrex Health Products	1994-12-05	34	0
K945334	CHERRY PIT DISSECTOR	Lorrex Health Products	1994-12-05	34	0
K945332	ROSEBUD DISSECTOR	Lorrex Health Products	1994-12-05	34	0
K940436	SPONGE, LAPAROTOMY, VARIOUS SIZE	Shawnee Products, Inc.	1994-07-26	176	0
K942366	LORREX GAUZE SPONGES, X-RAY DETECTABLE	Lorrex Health Products	1994-05-27	9	0
K941344	LAP SPONGE PRODUCT LINE	Cush Medical Products	1994-05-12	56	0
K941522	STERILE X-RAY DETECTABLE GAUZE SPONGES	Cush Medical Products	1994-05-12	43	0
K940762	ISOLYSER (18X18 X-RAY DETECTABLE)	Thantex Specialties, Inc.	1994-05-02	73	0
K940763	ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)	Thantex Specialties, Inc.	1994-05-02	73	0
K940756	ISOLYSER (X-RAY DETECTABLE)	Thantex Specialties, Inc.	1994-05-02	73	0
K940757	ISOLYSER (4X18) X-RAY DETECTABLE	Thantex Specialties, Inc.	1994-05-02	73	0
K941217	DUPAQUE SPONGE	Dumex Medical Surgical Products, Ltd.	1994-04-21	38	0
K934971	STERILE LAPAROTOMY SPONGES	Medsurg Industries, Inc.	1994-02-07	112	0
K935883	NEUROLOGICAL SPONGES	Mcneil Healthcare, Inc.	1994-02-03	56	0
K935993	SURGICAL SPONGE X-RAY DETECTABLE	Mcneil Healthcare, Inc.	1994-02-02	51	0
K935882	TONSIL SPONGES	Mcneil Healthcare, Inc.	1994-01-31	53	0
K935910	X-RAY PACKING SPONGE	Mcneil Healthcare, Inc.	1994-01-31	53	0
K935881	SPECIALTY SPONGES	Mcneil Healthcare, Inc.	1994-01-31	53	0
K932846	TENCEL X-RAY DETECTABLE SPONGES/LAP PADS	Courtaulds Fibers, Inc.	1993-12-09	182	0
K922054	STERILE GAUZE SPONGES X-RAY DETECTABLE	Team Mfg., Inc.	1992-08-10	98	0
K920356	SURGICAL SPONGES	Ultracell Medical Technologies, Inc.	1992-08-06	192	0
K920355	SPECIALTY SPONGES	Ultracell Medical Technologies, Inc.	1992-08-06	192	0
K913303	LAP SPONGES, MODIFIED	Carwild Corp.	1992-08-06	378	0
K913302	DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED	Carwild Corp.	1992-07-23	364	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