Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perimeter Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
89 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844924 | PERIMETER YANKAUER SUCTION TIPS & SETS | Perimeter Medical, Inc. | 1985-03-18 | 89 | 0 |
| K844922 | PERIMETER THORACIC CATHETER | Perimeter Medical, Inc. | 1985-03-18 | 89 | 0 |
| K844925 | PERIMETER MEDIASTINAL DRAIN | Perimeter Medical, Inc. | 1985-03-18 | 89 | 0 |
| K844923 | PERIMETER SUMP DRAIN | Perimeter Medical, Inc. | 1985-03-18 | 89 | 0 |
| K844921 | PERIMETER CLOSED WOUND RESEVOIR | Perimeter Medical, Inc. | 1985-03-18 | 89 | 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