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

MPA — Predicate Candidate Screening

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

90 daysmedian FDA review time

275 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242184	Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle	Alcon Laboratories, Inc.	2024-12-04	132	2
K233653	Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe	Peregrine Surgical, LLC	2024-08-05	265	0
K221872	ITrack Advance Canaloplasty Microcatheter with Advanced Deli	Nova Eye Inc. (Business Name Nova Eye Medical)	2023-03-30	275	0
K202670	Nam illumination probe with chopper	Oculight , Ltd.	2021-08-20	340	0
K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical , Ltd.	2015-09-11	88	0
K143123	Synergetics PHOTON EX	Synergetics	2015-02-24	116	0
K080067	ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER	Iscience Interventional	2008-07-18	190	1
K062895	XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII	Dutch Ophthalmic Research Center International BV	2006-10-13	16	0
K062259	ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100	Iscience Surgical	2006-08-15	11	0
K041108	ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA	Iscience Surgical Corporation	2004-06-22	55	0
K032598	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	2003-11-24	91	0
K000252	INSIGHT 4000 ENDOSCOPE	Insight Instruments Mfg., Inc.	2000-10-17	264	0
K000416	TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001	Retinalabs.Com	2000-05-08	90	0
K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	Peregrine Surgical , Ltd.	1998-05-19	78	0
K980530	PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK,	Peregrine Surgical , Ltd.	1998-05-12	90	0
K980027	PEREGRINE SHIELDED DIFFUSION PROBE	Peregrine Surgical , Ltd.	1998-03-31	85	0
K980025	PEREGRINE TAPERED DIFFUSION PROBE	Peregrine Surgical , Ltd.	1998-03-31	85	0
K973229	D.O.R.C. HEXON ILLUMINATION SYSTEM	Dutch Ophthalmic USA, Inc.	1997-11-25	90	0
K973293	SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR	Vaughan Weeks	1997-11-18	77	0
K973290	SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK	Vaughan Weeks	1997-11-14	73	0
K973757	D.O.R.C. SOLUX LIGHT SOURCE	Dutch Ophthalmic USA, Inc.	1997-11-07	36	0
K971679	I-SCOPE OPHTHALMIC ENDOSCOPE	Ophthalmic Technologies, Inc.	1997-06-25	49	0
K970882	ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.	American Medical Devices, Inc.	1997-06-24	106	0
K964005	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	1997-06-09	275	0
K970875	ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)	American Medical Devices, Inc.	1997-05-20	71	0
K964553	MBI CO-AXIAL ILLUMINATED RETINAL PICK	M.B. Industries, Inc.	1997-05-13	181	0
K964405	MBI ILLUMINATED RETINAL PICK	M.B. Industries, Inc.	1997-05-13	190	0
K971338	SYNTEC, INC. DISPOSABLE BARE END FIBER	Syntec, Inc.	1997-05-06	26	0
K970878	ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAM	American Medical Devices, Inc.	1997-05-06	57	0
K964555	VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)	Vitrotec, Inc.	1997-03-31	138	0
K963417	VITLITE (TR7700)	Escalon Trek Medical	1996-12-20	112	0
K961036	MBI FIBEROPTIC ENDO-ILLUMINATOR	M.B. Industries, Inc.	1996-07-15	123	0
K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	Storz	1996-03-26	84	0
K952581	GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR	Gamp & Assoc.	1996-01-05	214	0
K952585	GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR	Gamp & Assoc.	1996-01-05	214	0
K951627	INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM	Infinitech, Inc.	1995-10-19	195	0
K946136	INFINITECH LIGHTED INFUSION CANNULA	Surgical Technologies, Inc.	1995-10-02	290	0
K952580	GAMP & ASSOCIATES DISPOSABLE BARE END FIBER	Gamp & Assoc.	1995-09-01	88	0
K952586	GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	Gamp & Assoc.	1995-09-01	88	0
K952584	GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK	Gamp & Assoc.	1995-09-01	88	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