Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FSS — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
154 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091246 | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGH | Trumpf Medizin Systeme GmbH + Co. KG | 2009-09-28 | 154 | 0 |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR S | Medical Illumination International, Inc. | 2001-02-02 | 81 | 0 |
| K984124 | AESCULAP XENON LIGHT SOURCE | Aesculap, Inc. | 1999-02-01 | 75 | 0 |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | 1998-08-18 | 75 | 0 |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | 1998-07-29 | 68 | 0 |
| K981469 | CERMAX300 LIGHTSOURCE | Cuda Products Co. | 1998-07-09 | 77 | 0 |
| K980044 | XENON 300MX | Perkinelmer Optoelectronics | 1998-04-03 | 87 | 0 |
| K970886 | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | 1997-04-16 | 69 | 1 |
| K961971 | Q-5000 | Stryker Endoscopy | 1996-06-28 | 39 | 0 |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1996-04-30 | 43 | 0 |
| K930711 | TRI*STAR | Light Technology Systems | 1993-07-30 | 169 | 1 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | 1991-06-11 | 97 | 0 |
| K895950 | MODEL FEL5100 FLOOR LIGHT | F.W. Lang Co. | 1989-10-31 | 21 | 0 |
| K893813 | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | Astralite Corp. | 1989-07-14 | 52 | 0 |
| K891759 | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | 1989-04-19 | 27 | 0 |
| K891758 | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | 1989-04-19 | 27 | 0 |
| K882333 | FLOOR LIGHT | Commercial Products & Engineering Co. | 1988-06-23 | 17 | 0 |
| K880540 | LIGHT, SURGICAL, FLOOR STANDING | Ferguson Medical | 1988-02-24 | 15 | 0 |
| K880198 | GEMINI SURGICAL LIGHT | American Sterilizer Co. | 1988-02-10 | 26 | 0 |
| K860020 | MINOR SURGERY LIGHT MODEL 2112 | Adel Medical , Ltd. | 1986-01-24 | 21 | 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