Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FTD — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
163 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL S | Engineered Medical Solutions Co., LLC | 2013-12-05 | 27 | 0 |
| K130513 | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | 2013-05-08 | 70 | 17 |
| K123776 | POLARIS 100/200 | Drager Medical GmbH | 2013-03-08 | 88 | 0 |
| K111020 | ATRICURE DISSECTOR | AtriCure, Inc. | 2011-06-09 | 58 | 0 |
| K100234 | HM-LAMP II | Hillusa, Inc. | 2010-07-08 | 163 | 0 |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | 2010-06-25 | 87 | 0 |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007-06-20 | 51 | 0 |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | 2006-02-23 | 83 | 0 |
| K041681 | ATRICURE DISSECTOR | AtriCure, Inc. | 2004-07-01 | 10 | 0 |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | 2001-12-13 | 76 | 4 |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | 2001-06-07 | 87 | 5 |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC- | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 | 111 | 0 |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | 1998-06-30 | 46 | 0 |
| K961122 | STRYKER KNIFELIGHT | Stryker Instruments | 1996-08-22 | 154 | 0 |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | 1995-10-18 | 36 | 0 |
| K942553 | GENESIS | Burton Medical Products Corp. | 1994-06-23 | 23 | 0 |
| K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Medline Industries, Inc. | 1994-02-22 | 322 | 0 |
| K932451 | HANAULUX 2005 SURGICAL LIGHT | Heraeus Instruments GmbH | 1993-11-12 | 176 | 1 |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Medical Illumination, Inc. | 1993-06-25 | 123 | 0 |
| K895715 | HANAULUX(R) 2000 | W.C. Heraeus GmbH | 1989-10-13 | 18 | 4 |
| K882613 | ALM SURGICAL LAMPS | Alm Surgical Equipment, Inc. | 1988-07-18 | 24 | 2 |
| K860088 | PL EXAM LIGHT | Burton Medical Products Corp. | 1986-01-24 | 14 | 0 |
| K841360 | MINOR SURGICAL LIGHT MODEL 180 | American Sterilizer Co. | 1984-04-24 | 22 | 0 |
| K823360 | SURGICAL LIGHT | Amsco Co. | 1982-12-03 | 28 | 0 |
| K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT | Sybron Corp. | 1981-07-20 | 32 | 0 |
| K801353 | PARKE-DAVIS SURGICAL LIGHT | Warner-Lambert Co. | 1980-06-30 | 21 | 0 |
| K770861 | SURGICAL COLDLIGHT, AX8 | Affiliated Hospital Products, Inc. | 1977-06-17 | 39 | 0 |
| K770568 | SURGICAL ILLUMINATOR (SIL) | Fiber Optics Engineering, Inc. | 1977-04-14 | 20 | 0 |
| K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) | Fiber Optics Engineering, Inc. | 1977-04-14 | 20 | 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