Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Peters Surgical · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
378 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233265 | Monotime and Optime R | Peters Surgical | 2024-10-11 | 378 | 0 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | 2024-07-12 | 339 | 0 |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Peters Surgical | 2007-08-03 | 88 | 0 |
| K060465 | PREMIO | Peters Surgical | 2007-01-17 | 329 | 0 |
| K060163 | CARDIOFLON, CARDIOXYL | Peters Surgical | 2006-10-11 | 261 | 2 |
| K062366 | OPTIME, SINUSORB PGA | Peters Surgical | 2006-10-02 | 49 | 0 |
| K052701 | COROLENE | Peters Surgical | 2005-12-13 | 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