Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAD — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
356 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2024-01-19 | 98 | 0 |
| K202887 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020-10-27 | 29 | 0 |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2020-08-13 | 30 | 0 |
| K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020-06-25 | 141 | 0 |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2018-12-13 | 30 | 0 |
| K181228 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2018-08-31 | 115 | 0 |
| DEN160062 | IlluminOss Bone Stabilization System | Illminoss Medical, Inc. | 2017-12-19 | 356 | 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