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

HOZ — Predicate Candidate Screening

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

73 daysmedian FDA review time

226 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K132796	SUNTOUCH EYE SPEAR	Huizhou Foryou Medical Devices Co., Ltd.	2013-10-30	54	0
K130117	NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS	Network Medical Products, Ltd.	2013-10-29	286	0
K091240	ALPHAMED SURGICAL SPEAR, MODEL 70-5000	Alphamed, Inc.	2009-10-23	179	0
K082460	CENEFOM PVA SURGICAL SPEAR	Longtek Scientific Co., Ltd.	2008-12-15	111	0
K012196	ULTRACELL ABSORBENT STICK	Ultracell Medical Technologies, Inc.	2001-08-24	42	0
K011191	MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHT	Medtronic Xomed, Inc.	2001-06-26	68	0
K003842	PRESCOTT'S SURGICAL SPEAR	Prescott'S, Inc.	2001-04-13	122	0
K002279	ML EYE SPEAR, MODEL ML 27 ES	Med-Logics, Inc.	2000-08-18	23	0
K993883	M-PACT CORNEAL LIGHT SHIELD	M-Pact Corp.	1999-12-21	36	0
K990671	DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SH	Hurricane Medical	1999-05-10	69	0
K990749	SOF-SUCTION FLUID EVACUATION SYSTEM	X-Tech Medical, LLC	1999-04-02	25	0
K982599	THE FREMSTAD RING	Ophthalmic Solutions, LLC	1999-02-16	204	0
K974313	HYDROFERA SURGICAL SPEAR	Hydrofera, LLC	1998-03-02	105	0
K972633	ULTRACELL SUCTION SPONGE	Ultracell Medical Technologies, Inc.	1997-12-17	156	0
K972693	DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR	Deroyal Industries, Inc.	1997-09-30	74	0
K971832	IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EY	M-Pact Worldwide Management Corp.	1997-07-31	73	2
K964855	EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIE	Shippert Medical Technologies Corp.	1997-03-04	90	0
K946016	IVALON OPHTHALMIC SPONGE	Ivalon	1995-03-22	103	0
K950241	OPHTHALMIC SPONGES	Oasis Medical, Inc.	1995-02-27	38	0
K942642	SURGI-WIPE	Surgin Surgical Instrumentation, Inc.	1994-07-15	42	0
K933872	VISI-SPEAR EYE SPONGE	Visitec Co.	1993-12-27	143	0
K923922	SURGICAL SPEARS	Ultracell Medical Technologies, Inc.	1993-03-19	226	3
K920354	OPHTHALMIC SPONGES	Ultracell Medical Technologies, Inc.	1992-08-05	191	1
K910707	OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS	Jedmed Instrument Co.	1991-04-10	49	0
K902750	VISI-SWAB OPHTALMIC SPONGE	Visitec Co.	1990-07-26	34	0
K900786	VISI-SORB ABSORBANT STICK	Visitec Co.	1990-05-18	87	0
K897034	K-SPONGE	Katena Products, Inc.	1990-02-15	59	0
K896705	VISITEC MICRO-SPONGE SPEARS	Visitec Co.	1990-01-11	44	0
K896084	MICROSPEARS	Sparta Surgical Corp.	1989-11-02	14	0
K896004	ALCON SURGICAL SPONGE	Alcon Laboratories	1989-11-02	20	0
K885232	FLUID DRAINAGE WICK	Visitec Co.	1989-02-08	50	0
K872612	SOLOS EYESITE SPONGES	Solos Ophthalmology	1987-07-31	25	0
K852055	ASCON OPHTHALMIC SPONGE	Ascon Medical Instruments, Ltd.	1985-09-04	118	0
K842983	AMPCO OPTHALMIC TRAY	Associated Medical Products Co.	1985-05-22	296	0
K850340	EYE PROCEDURE PACK	Marwood Medical, Inc.	1985-05-22	114	0
K842601	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	Ophthalmic Resources, Inc.	1985-05-10	309	0
K842990	STERILE EYE SURGERY KITS	Biological & Environmental Control Laboratories	1985-05-09	283	0
K850050	PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK	Professional Medical Services	1985-04-23	105	0
K850883	SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11	Storz Instrument Co.	1985-03-20	16	0
K841721	OPERAID SURGICAL DRAIN	Jedmed Instrument Co.	1984-11-21	210	0
K834356	EYE SPONGE OR SPEAR	Jedmed Instrument Co.	1984-03-16	94	0
K840471	EYE SPEAR	Surgicot, Inc.	1984-03-16	42	0
K830262	FLORET OPHTHALMIC EYE SPEAR	Ritmed, Inc.	1983-04-06	71	0
K802794	PRO-OPHTA STICKS	Secol Co.	1980-12-22	48	0
K780987	SOFT SILICONE ELASTOMER SPONGE EXPLANT	Medical Instrument Research Assoc., Inc.	1978-09-28	106	0
K780257	MICROSPEARS	Sparta Instrument Corp.	1978-02-23	8	0
K761155	CELLULOSE EYE STICK	Winn Hirsch & Assoc.	1976-12-16	17	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