Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FCW · Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
109 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131226 | NOVAPROBE LED LIGHT SOURCE | Novaprobe Incorporated | 2014-07-24 | 450 | 0 |
| K123956 | POWER LED 175 | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 | 35 | 0 |
| K123359 | OVS1 VIDEO SYSTEM | Olive Medical Corp. | 2012-12-19 | 49 | 0 |
| K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | Richard Wolf Medical Instruments Corp. | 2012-09-20 | 100 | 0 |
| K093792 | LED LIGHT SOURCE | Sunoptic Technologies, LLC | 2010-03-18 | 98 | 0 |
| K091968 | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, | KARL STORZ Endoscopy-America, Inc. | 2009-09-14 | 75 | 0 |
| K082813 | STRYKER LED LIGHTSOURCE | Stryker Corp. | 2008-12-19 | 86 | 1 |
| K081477 | LUXTEC MLX LIGHT SOURCE | Integra Luxtec, Inc. | 2008-06-18 | 22 | 4 |
| K032430 | ACUEITY MEDICAL LIGHT SOURCE | Acueity, Inc. | 2003-09-05 | 30 | 0 |
| K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | Circon Video | 2001-10-17 | 90 | 0 |
| K000229 | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOU | Videolabs, Inc. | 2000-03-21 | 54 | 0 |
| K993300 | COLDLIGHTSOURCE PL3000 | Fiber Imaging Technologies, Inc. | 1999-11-05 | 35 | 0 |
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | Angiolaz, Inc. | 1999-10-20 | 90 | 0 |
| K970598 | INTEGRATED VISUALIZATION SYSTEM | Urohealth, Inc. | 1997-03-12 | 22 | 0 |
| K964586 | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 | Iba/Griffith | 1997-01-17 | 63 | 0 |
| K963043 | ENDOSPOT | Corin USA | 1996-09-20 | 46 | 0 |
| K951647 | WELCH ALLYN HI - LUX ILLUMINATOR | Welch Allyn, Inc. | 1995-05-17 | 37 | 0 |
| K945420 | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | 1994-12-08 | 34 | 0 |
| K942155 | HMT ENDOSCREEN, MODEL ESC 501 | Servicetrends, Inc. | 1994-07-01 | 59 | 0 |
| K934531 | AUTO SUTURE DISPOSABLE LIGHT CABLE | United States Surgical, A Division of Tyco Healthc | 1994-05-18 | 240 | 0 |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Cuda Products Co. | 1994-01-03 | 178 | 0 |
| K905376 | STORZ S6000 LIGHT SOURCE | Storz Instrument Co. | 1991-01-23 | 54 | 0 |
| K903790 | ENDOSCOPIC LIGHT SOURCE 250 ENDO | Orlux Engineering and Instrumentation | 1990-12-07 | 109 | 0 |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Luxtec Corp. | 1989-04-26 | 72 | 0 |
| K864385 | LUXTEC LIGHT SOURCES | Luxtec Corp. | 1987-01-13 | 69 | 1 |
| K852951 | WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS | Welch Allyn, Inc. | 1985-08-27 | 47 | 0 |
| K842609 | R.L. MEDICAL TWIN LIGHT SOURCE | Tridak Division of Indicon, Inc. | 1984-08-09 | 35 | 0 |
| K832807 | PEDIATRIC ILLUMINATING URETERAL | Van-Tec, Inc. | 1983-10-19 | 62 | 0 |
| K771739 | PENTAX LH-150F LIGHT SOURCE | Pilling Co. | 1977-09-30 | 15 | 0 |
| K760647 | ADAPTER, FIBER OPTICS HEADLIGHT | Pilling Co. | 1976-12-06 | 82 | 0 |
| K760176 | FLOORSTAND, FIBER OPTIC LIGHT SOURCE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 | 55 | 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