Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phakosystems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880081 | VISION CARE/PHAKOSYSTEMS ECHOPACH | Phakosystems, Inc. | 1988-03-15 | 64 | 0 |
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | Phakosystems, Inc. | 1987-11-23 | 189 | 0 |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | Phakosystems, Inc. | 1986-02-19 | 27 | 0 |
| K851674 | PHAKOSYSTEMS MODEL CES 4100 | Phakosystems, Inc. | 1985-08-05 | 104 | 0 |
| K830871 | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION | Phakosystems, Inc. | 1983-06-02 | 76 | 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