Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FTA — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
204 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | 2015-09-22 | 204 | 0 |
| K142386 | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | 2014-09-29 | 33 | 0 |
| K133554 | SURGICAL LIGHT HANDLE COVER | Microtek Medical, Inc. an Ecolab Company | 2014-04-08 | 140 | 0 |
| K133413 | IDSS SLC | Black Diamond Video | 2014-01-07 | 61 | 0 |
| K112133 | OASYS SURGICAL LIGHT CONTROLLER | Oasys Healthcare | 2012-03-01 | 219 | 0 |
| K102791 | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | Image Stream Medical, Inc. | 2010-11-23 | 57 | 0 |
| K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | 2008-07-30 | 43 | 0 |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | 2006-01-19 | 50 | 0 |
| K051505 | SCB/STERIS OR-LIGHT INTERFACE BOX | KARL STORZ Endoscopy-America, Inc. | 2005-08-11 | 65 | 0 |
| K023704 | KSEA SCB ACC CONTROL | KARL STORZ Endoscopy-America, Inc. | 2003-01-30 | 87 | 0 |
| K020640 | KSEA SCB MEDIA CONTROL | KARL STORZ Endoscopy-America, Inc. | 2002-05-28 | 90 | 0 |
| K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | Aspen Surgical Products, Inc. | 2002-02-14 | 16 | 0 |
| K993089 | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | Deroyal Cardiovascular, Inc. | 1999-10-14 | 28 | 0 |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | 1996-01-17 | 79 | 0 |
| K935102 | SATURN LIGHT | Burton Medical Products Corp. | 1994-06-27 | 248 | 0 |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | 1992-02-06 | 90 | 0 |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | 1990-03-20 | 7 | 0 |
| K894397 | WELCON LIGHT HANDLE | Welcon, Inc. | 1989-08-10 | 21 | 0 |
| K890866 | TC SYSTEM-HANDLE | Transmedical Corp. | 1989-03-14 | 21 | 0 |
| K890867 | TC SYSTEM-COVER | Transmedical Corp. | 1989-03-14 | 21 | 0 |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Kleen Test Products | 1989-02-27 | 24 | 0 |
| K882132 | LIGHT, SURGICAL ACCESSORIES | Charles Polo & Co., Inc. | 1988-06-15 | 26 | 0 |
| K871034 | LCA 2000 | Vistek Corp. | 1987-04-10 | 24 | 0 |
| K862010 | CHICK SURGICAL LIGHT | Professional Medical Products, Inc. | 1986-06-09 | 12 | 0 |
| K810292 | CAM-WRAP | Medline Industries, Inc. | 1981-03-04 | 29 | 0 |
| K780162 | DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 | Cavitron Corp. | 1978-03-27 | 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