Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micrins Surgical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
270 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993970 | MICRINS MICROSURGICAL SUTURE | Micrins Surgical, Inc. | 2000-03-30 | 128 | 0 |
| K982278 | MICRINS MICRO ANASTOMOSIS CLAMP | Micrins Surgical, Inc. | 1999-03-26 | 270 | 0 |
| K933310 | MICRINS CONTRAST BACKGROUND MATERIAL | Micrins Surgical, Inc. | 1993-08-19 | 43 | 0 |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | 1987-08-21 | 21 | 0 |
| K872991 | MICRINS FORCEPS 2010 | Micrins Surgical, Inc. | 1987-08-17 | 17 | 0 |
| K872990 | MICRINS SURGICAL SCISSOR | Micrins Surgical, Inc. | 1987-08-17 | 17 | 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