Atlas FDA

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

HBI — Predicate Candidate Screening

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

73 daysmedian FDA review time
190 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223183Light-Guide CablesOlympus Winter & Ibe GmbH2023-01-13930
K163185OptiLux LED IlluminatorIsolux, LLC2016-11-2170
K141781KOGENT SPETZLER LIGHTED SUCTION TUBESKatalyst Surgical, LLC2015-04-092810
K111342LIGHT GUIDE CABLESchott North America2011-11-251960
K0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEIsolux, LLC2005-10-3170
K021931ENDOSCOPIC FIBEROPTIC CABLEGulf Medical Fiberoptics2002-09-06860
K991208ENDOSCOPIC FIBEROPTIC CABLEIsolux America1999-06-23750
K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100Cuda Products Co.1998-12-16900
K933593LUMINOUS 150 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1993-10-28940
K922837S1500 XENON LIGHT SOURCEEndomedix1992-11-031440
K922462NEXTEC FIBEROPTIC CABLESNextec Corp.1992-09-211180
K921866LUMINOUS 250 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1992-07-08790
K920167NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELNextec Corp.1992-03-23730
K904616STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATORStorz Instrument Co.1991-04-191900
K904681VLS 5300 300W XENON LIGHT SOURCEVistek Corp.1990-12-18640
K904609XENON LIGHT SOURCEMedical Dynamics, Inc.1990-12-18680
K901108FIBERLUMEBurton1990-03-28190
K896549STORZ FIBEROPTIC ENDO-ILLUMINATORSStorz Instrument Co.1990-02-15900
K890398RYAN-STYLE DIRECTED INFUSION MANIPULATORAdvanced Surgical Products, Inc.1989-02-17240
K883857FIBEROPTIC WIRE PICK LIGHTPIPEAdvanced Surgical Products, Inc.1988-09-29160
K883858FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPEAdvanced Surgical Products, Inc.1988-09-29160
K883856FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPEAdvanced Surgical Products, Inc.1988-09-29160
K883201VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSVital Metrics, Inc.1988-09-26600
K882956VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATIONVital Metrics, Inc.1988-08-03210
K854587STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPEStorz Instrument Co.1986-02-04780
K853948MINNESOTA SCIENTIFIC, INC. OMNI-BEAMMinnesota Scientific, Inc.1985-10-16220
K810300FIBER OPTIC ADAPTERS#60-0893Aspen Laboratories, Inc.1981-02-27240
K810299FIBER OPTIC ADAPTERS#60-0891Aspen Laboratories, Inc.1981-02-27240

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