Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mani, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 | 141 | 0 |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | 2006-05-19 | 141 | 0 |
| K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) | Mani, Inc. | 2006-03-14 | 75 | 6 |
| K050150 | MANI NEEDLE & SUTURE PACK | Mani, Inc. | 2005-12-05 | 315 | 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