Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unimax Medical Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
386 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021-11-05 | 168 | 0 |
| K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | Unimax Medical Systems, Inc. | 2011-12-20 | 386 | 0 |
| K112358 | UNIMAX TROCAR SYSTEM | Unimax Medical Systems, Inc. | 2011-10-17 | 62 | 0 |
| K111622 | UNIMAX ANTI-FOG SOLUTION | Unimax Medical Systems, Inc. | 2011-09-09 | 91 | 0 |
| K111441 | UNIMAX VERESS NEEDLE | Unimax Medical Systems, Inc. | 2011-08-19 | 87 | 0 |
| K103509 | UNIMAX SUCTION IRRIGATION SET | Unimax Medical Systems, Inc. | 2011-05-19 | 171 | 0 |
| K103510 | UNIMAX SPECIMEN RETRIEVAL SYSTEM | Unimax Medical Systems, Inc. | 2011-05-06 | 158 | 1 |
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