Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCS — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
377 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Sourc | Stryker Endoscopy | 2015-08-20 | 101 | 0 |
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Stryker Corp. | 2006-09-28 | 115 | 0 |
| K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III | Stryker Endoscopy | 1998-09-22 | 63 | 1 |
| K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | Rocket of London, Ltd. | 1995-08-15 | 377 | 0 |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Gabriel Medical, Inc. | 1995-02-07 | 113 | 0 |
| K941506 | URETERAL ILLUMINATOR | Apple Medical Corp. | 1994-10-05 | 190 | 0 |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | Gabriel Medical, Inc. | 1994-05-02 | 119 | 0 |
| K923436 | ILLUMINATED URETERAL CATHETER | Cook Urological, Inc. | 1993-03-05 | 235 | 1 |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Laser Peripherals, LLC | 1988-03-23 | 131 | 0 |
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Laserguide | 1988-03-22 | 71 | 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