Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FFS — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
183 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Cook Urological, Inc. | 2007-11-20 | 74 | 1 |
| K061622 | PS SERIES | Photonic Optische Gerate Gesmbh & Cokg | 2007-03-05 | 266 | 0 |
| K063309 | TRU-CABLE | Truphatek International, Ltd. | 2007-01-12 | 71 | 0 |
| K061025 | ACCUTECH ENDOLITE PROBE | Accutech Medical Technologies, Inc. | 2006-05-31 | 48 | 0 |
| K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | Sovis Optique | 2002-12-31 | 63 | 0 |
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Cogent Light Technologies, Inc. | 2000-07-17 | 45 | 0 |
| K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES | Smith & Nephew, Inc. | 2000-01-20 | 48 | 1 |
| K991323 | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR | Smith & Nephew, Inc. | 1999-07-06 | 78 | 0 |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | Cogent Light Technologies, Inc. | 1998-12-23 | 63 | 0 |
| K982462 | FIBER OPTIC ENDOILLUMINATION PROBE | Microvision, Inc. | 1998-09-14 | 61 | 0 |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | Dutch Ophthalmic USA, Inc. | 1998-05-20 | 90 | 0 |
| K970217 | VISTA ILLUMINATION SYSTEM | Vista Medical Technologies, Inc. | 1997-04-02 | 71 | 0 |
| K962595 | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS | KARL STORZ Endoscopy-America, Inc. | 1996-09-04 | 64 | 0 |
| K950960 | REDDY ILLUMINATOR | Luxtec Corp. | 1995-09-08 | 190 | 0 |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Alm Surgical Equipment, Inc. | 1994-11-04 | 17 | 0 |
| K944688 | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1994-11-01 | 40 | 0 |
| K940963 | XENON LIGHT SOURCE | Incredivision, Inc. | 1994-04-08 | 37 | 0 |
| K940962 | LIQUID LIGHT 500 | Incredivision, Inc. | 1994-04-08 | 37 | 0 |
| K933216 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ Endoscopy-America, Inc. | 1993-09-09 | 135 | 0 |
| K892145 | FIBER OPTIC LIGHT TRANSMISSION CABLE | Opto Vision, Inc. | 1989-09-29 | 183 | 0 |
| K893440 | FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 | Welch Allyn, Inc. | 1989-07-28 | 86 | 0 |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | Mira, Inc. | 1989-05-08 | 101 | 0 |
| K844773 | EFF-EFFNER BULBS | Mecron Medical Products, Inc. | 1985-01-08 | 29 | 0 |
| K834576 | REAL FIBER OPTIC URETERAL TRANSILLUMIN | Douglas Manufacturer Co. | 1984-04-20 | 113 | 0 |
| K840605 | LABORIE FIBREOPTIC LIGHT CABLE | Tridak Division of Indicon, Inc. | 1984-04-13 | 63 | 0 |
| K834487 | FLEXIBLE LIQUID LIGHT GUIDE | Endo Lase, Inc. | 1984-02-21 | 70 | 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