Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renovo, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
173 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | 2018-03-19 | 102 | 0 |
| K173741 | Reprocessed ArthoCare Ablation Wand | Renovo, Inc. | 2018-03-05 | 88 | 0 |
| K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | 2018-02-21 | 173 | 0 |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon U | Renovo, Inc. | 2017-10-06 | 87 | 0 |
| K172093 | Reprocessed Covidien Trocar | Renovo, Inc. | 2017-10-05 | 86 | 0 |
| K172092 | Reprocessed Shavers/Burs | Renovo, Inc. | 2017-10-04 | 85 | 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