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

FST — Predicate Candidate Screening

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

70 daysmedian FDA review time

126 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200874	TruView Light Cable, TruView Lateral Retractor Light Cable,	Innovasis, Inc.	2020-06-30	90	0
K141330	ENDO-CORD	Enroxtech, Inc.	2014-12-15	208	0
K122637	LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999	Stryker Spine	2012-11-01	64	0
K113697	EIGR SURGICAL ILLUMINATION SYSTEM	Invuity, Inc.	2012-02-10	56	0
K113330	CABLECAP	Sensormed	2012-01-12	59	0
K102266	ISOLED AC-POWERED LED HEADLIGHT SYSTEM	Isolux, LLC	2010-09-24	45	0
K101496	CABLECAP MODEL: WLF, STZ, ACM	Sensormed	2010-09-14	105	0
K100388	21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING S	Medical Illumination International, Inc.	2010-06-22	126	0
K100395	HARMONY VLED SURGICAL LIGHTNING SYSTEM	STERIS Corporation	2010-03-17	29	1
K093386	CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HE	Bfw, Inc.	2010-01-28	90	0
K090070	INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM	Invuity, Inc.	2009-04-22	100	0
K083710	RETRACTOR LITE	Thomas Surgical Instruments, Inc.	2009-02-23	70	0
K082992	AXXION LIGHT GUIDE	Spinal Elements, Inc.	2009-02-18	134	0
K080962	LITE WAND II	Thompson Surgical Instruments, Inc.	2008-06-25	82	0
K080367	ZIMMER MIS LIGHT	Zimmer Spine, Inc.	2008-02-22	10	0
K071218	PROXENON 350, MODEL 902XX	Welch Allyn, Inc.	2007-06-14	43	0
K061690	SURGICAL HEADLIGHT	Gulf Medical Fiberoptics	2006-09-15	92	1
K053227	LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMIN	Medical Illumination International, Inc.	2006-01-13	57	0
K051786	MELIDE FIBEROPTIC LIGHT	Designs For Vision, Inc.	2005-08-15	45	0
K042034	NUVASIVE MAXCESS LIGHT GUIDE	Nuvasive, Inc.	2004-10-26	89	0
K003577	STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT	STERIS Corporation	2001-01-29	70	0
K000728	MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE	Medtronic Xomed	2000-03-21	15	0
K991572	ISOLUX SURGICAL HEADLIGHT	Isolux America	1999-07-08	64	0
K972225	UFR FIBEROPTIC CABLE	Universal Fiberoptic Repair, Inc.	1998-03-18	278	0
K955510	X6000D SILENT SUN LIGHT SOURCE	Products For Medicine	1996-01-31	58	0
K936048	LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)	Cogent Light Technologies, Inc.	1994-03-10	80	0
K931546	END-IRRIGATING ENDOILLUMINATOR	Infinitech, Inc.	1994-02-09	317	0
K922820	WOODBINE XT350, XENON ARC LIGHT SOURCE	Woodbine Ptical Corp.	1992-09-02	83	0
K922544	MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE	Kirschner Medical Corp.	1992-08-07	70	0
K921646	NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON	Nextec Corp.	1992-05-13	37	0
K915274	METAL HALIDE LIGHT SOURCE MODEL LM 250	Pentax Precision Instrument Corp.	1992-01-23	59	0
K912252	INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT	Fiberoptic Medical Products, Inc.	1991-06-27	37	0
K903800	FIBER OPTIC LIGHT CABLE	Orlux Engineering and Instrumentation	1990-08-29	9	0
K901491	CUDA SURGICAL LIGHT	Cuda Products Co.	1990-06-18	81	0
K901035	FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE	Cuda Products Co.	1990-04-23	48	0
K893828	ML-800 AUTOELECTRONIC LIGHT SOURCE	M.P. Video, Inc.	1989-07-24	61	0
K893491	MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300	Cuda Products Co.	1989-06-22	49	0
K875004	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK	Advanced Surgical Products, Inc.	1988-03-14	101	0
K875007	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.	Advanced Surgical Products, Inc.	1988-03-14	101	0
K875005	PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.	Advanced Surgical Products, Inc.	1988-03-14	101	0
K875006	PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK	Advanced Surgical Products, Inc.	1988-03-14	101	0
K875195	OPHTHALMIC LIGHT PIPE PICK	Trek Medical Products, Inc.	1988-03-07	81	0
K870942	MVS FIBEROPTIC LIGHTPIPE	Advanced Surgical Products, Inc.	1987-04-03	25	0
K864380	LUTEX HEADLIGHT SYSTEMS	Luxtec Corp.	1986-11-19	14	8
K761142	HEADLIGHTS W/ FILTER-OPTICO CABLES	Pilling Co.	1977-01-05	40	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