Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phakos — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200911 | MIRA Adapter | Phakos | 2020-06-02 | 57 | 0 |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018-10-25 | 303 | 0 |
| K180195 | Frigitronics adapter | Phakos | 2018-03-16 | 51 | 0 |
| K162756 | PHAKOS Disposable Retinal Cryo Probe | Phakos | 2017-05-03 | 215 | 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