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

Visitec Co. — Predicate Candidate Screening

49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

52 daysmedian FDA review time

145 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K953394	VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}	Visitec Co.	1995-10-12	87	0
K945114	VISITEC SCLERAL PLUG	Visitec Co.	1995-02-23	128	0
K945738	VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE	Visitec Co.	1995-02-14	83	0
K945172	VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS	Visitec Co.	1995-01-17	88	0
K942234	VISITEC PRECISE-POINT	Visitec Co.	1994-07-12	64	0
K934269	FIBEROPTIC ILLUMINATED INSTRUMENTS	Visitec Co.	1994-05-17	259	0
K940210	VISITEC EYE PAD	Visitec Co.	1994-03-07	52	0
K933872	VISI-SPEAR EYE SPONGE	Visitec Co.	1993-12-27	143	0
K923972	OPHTHALMIC FLUID DISTRIBUTION SETS	Visitec Co.	1992-11-04	89	0
K922530	VISITEC MICROSURGICAL SUTURE	Visitec Co.	1992-10-20	145	0
K923645	VISITEC ASPIRATING SYRINGE	Visitec Co.	1992-09-30	71	0
K915808	AQUEOUS PARACENTESIS PIPET	Visitec Co.	1992-03-19	86	0
K915809	VISITEC CANALICULAR STENT	Visitec Co.	1992-02-24	62	0
K910516	DISPOSAL PAD FOR SHARPS	Visitec Co.	1991-04-29	83	0
K904074	VITREORETINAL INFUSION CANNULA	Visitec Co.	1991-02-26	175	0
K902857	VISI-DRAPE OPHTHALMIC DRAPES	Visitec Co.	1990-07-31	32	0
K902750	VISI-SWAB OPHTALMIC SPONGE	Visitec Co.	1990-07-26	34	0
K902010	VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE	Visitec Co.	1990-06-20	48	0
K900786	VISI-SORB ABSORBANT STICK	Visitec Co.	1990-05-18	87	0
K896622	VISITEC VITRECTOMY UNIT	Visitec Co.	1990-04-04	134	0
K896705	VISITEC MICRO-SPONGE SPEARS	Visitec Co.	1990-01-11	44	0
K896681	SOFT CORNEAL LIGHT SHIELD	Visitec Co.	1990-01-11	45	0
K885232	FLUID DRAINAGE WICK	Visitec Co.	1989-02-08	50	0
K884924	VISI-WIPE	Visitec Co.	1989-01-31	64	0
K853035	HESSBURG LIGHT GUARD	Visitec Co.	1985-12-13	148	0
K853961	VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100	Visitec Co.	1985-12-13	79	0
K852529	HESSBURG GLIDE UNTRAOCULAR LENS GUIDES	Visitec Co.	1985-09-24	102	0
K853243	VISITEC IRRIGATION CONTROL SYSTEM	Visitec Co.	1985-09-11	41	0
K852032	OCULAR PRESSURE REDUCER (MCCANNEL)	Visitec Co.	1985-08-12	95	0
K853135	VISITEC 2 MICRON FLUID FILTER	Visitec Co.	1985-08-09	14	0
K843487	VISITEC OPHTHALMIC FLUID DISTRIB- SET	Visitec Co.	1985-03-13	188	0
K844038	VISITEC MAGNIFYING SPECTACLES	Visitec Co.	1984-11-29	44	0
K843195	VISITEC FLIERINGA-LEGRAND FIXATION RING	Visitec Co.	1984-10-05	52	0
K843196	VISITEC EYE SPECULUM	Visitec Co.	1984-10-05	52	0
K843197	VISITEC EYE SHIELD	Visitec Co.	1984-10-05	52	0
K843592	VICO MICRO SURGICAL INSTRUMENTS	Visitec Co.	1984-10-05	23	0
K831901	LACIMAL INTUBATION SETS	Visitec Co.	1983-07-12	28	0
K831996	MICRO SURGICAL HANDLE	Visitec Co.	1983-07-12	21	0
K820618	MICROSURGERY KNIFE	Visitec Co.	1982-04-09	32	1
K812723	PEARCE CORNEAL TREPHINE	Visitec Co.	1981-10-13	15	0
K811965	VISITEC NEEDLE RANGE (GASTERUROLOGY)	Visitec Co.	1981-08-25	46	0
K811960	VISITEC NEDDLE TANGE (SURGERY)	Visitec Co.	1981-08-07	28	0
K811966	VISITEC NEEDLE RANGE (GENERAL HOSPITAL)	Visitec Co.	1981-07-23	13	0
K811961	VISITEC NEEDLE RANGE (ORTHOPAEDIC)	Visitec Co.	1981-07-20	10	0
K811964	VISITEC NEEDLE RANGE (CARDIOVASCULAR)	Visitec Co.	1981-07-20	10	0
K811963	VISITEC NEEDLE RANGE (ANESTHESIOLOGY)	Visitec Co.	1981-07-16	6	0
K782169	NEEDLES, CANNULAS, CYSTOTOMES	Visitec Co.	1979-02-13	46	0
K790243	CANNULAS	Visitec Co.	1979-02-12	45	0
K790244	CYSTOTOMES	Visitec Co.	1979-02-12	45	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