Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Winn Hirsch & Assoc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
96 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Winn Hirsch & Assoc. | 1988-02-29 | 35 | 0 |
| K864375 | TYPE 316L COTTER WIRE | Winn Hirsch & Assoc. | 1987-05-20 | 196 | 0 |
| K832213 | GAUZE CONVERSION CLASS II STERILE | Winn Hirsch & Assoc. | 1983-07-26 | 14 | 0 |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | Winn Hirsch & Assoc. | 1983-07-26 | 14 | 0 |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Winn Hirsch & Assoc. | 1983-03-17 | 28 | 0 |
| K812390 | NEUROSPONGE PADDIE | Winn Hirsch & Assoc. | 1981-11-24 | 96 | 0 |
| K812391 | NEUROSPONGES | Winn Hirsch & Assoc. | 1981-11-24 | 96 | 0 |
| K800195 | COTTON UNDER CAST PADDING | Winn Hirsch & Assoc. | 1980-02-11 | 13 | 0 |
| K761155 | CELLULOSE EYE STICK | Winn Hirsch & Assoc. | 1976-12-16 | 17 | 0 |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Winn Hirsch & Assoc. | 1976-10-15 | 51 | 0 |
| K760365 | BLANKET, BURN | Winn Hirsch & Assoc. | 1976-08-11 | 8 | 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