Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pixee Medical — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
212 daysmedian FDA review time
232 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243975 | Knee+ | Pixee Medical | 2025-03-20 | 87 | 0 |
| K233899 | Knee+ | Pixee Medical | 2024-03-08 | 88 | 0 |
| K230789 | Knee+ | Pixee Medical | 2023-04-21 | 30 | 0 |
| K220104 | Knee+ | Pixee Medical | 2022-09-01 | 232 | 0 |
| K213922 | FX SPS | Pixee Medical | 2022-07-22 | 219 | 0 |
| K202750 | Knee+ | Pixee Medical | 2021-04-21 | 212 | 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