Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FSW · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
110 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | 2002-11-25 | 77 | 0 |
| K013511 | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | Aculux, Inc. | 2002-02-01 | 102 | 0 |
| K943342 | MEDICAM XENON LIGHT SOURCE | M.P. Video, Inc. | 1994-10-17 | 97 | 0 |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Cuda Products Co. | 1993-11-18 | 72 | 0 |
| K922279 | ILLUMINATOR IV MINOR SURGERY LIGHT | Medical Illumination, Inc. | 1992-09-02 | 110 | 0 |
| K913135 | LM-300TWIN | Leisegang Medical, Inc. | 1991-09-18 | 64 | 0 |
| K894319 | MEDICAL DYNAMICS LIGHT SOURCE | Medical Dynamics, Inc. | 1989-10-03 | 81 | 0 |
| K870898 | ULTRA-LUX LIGHT SOURCE | Medline Industries, Inc. | 1987-03-18 | 13 | 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