Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
F.M. Wiest USA, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
376 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921871 | HYSTEROMAT(TM) 3700 | F.M. Wiest USA, Inc. | 1994-12-15 | 969 | 0 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 | 376 | 0 |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | 1992-07-23 | 167 | 0 |
| K915751 | URETEROMAT 4400 | F.M. Wiest USA, Inc. | 1992-04-24 | 123 | 0 |
| K911844 | HYSTEROFLATOR 1500 | F.M. Wiest USA, Inc. | 1991-11-21 | 210 | 0 |
| K912071 | SPACE(TM) 7500 | F.M. Wiest USA, Inc. | 1991-07-09 | 60 | 0 |
| K910883 | LAPAROFLATOR ELECTRONIC 3509 | F.M. Wiest USA, Inc. | 1991-03-29 | 28 | 0 |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | 1988-03-02 | 78 | 0 |
| K871181 | ARTHROCOMBI 5003 | F.M. Wiest USA, Inc. | 1987-09-29 | 188 | 0 |
| K871180 | ARTHRO AUTOMAT 5002 | F.M. Wiest USA, Inc. | 1987-09-29 | 188 | 0 |
| K865066 | ARTHROFLATOR | F.M. Wiest USA, Inc. | 1987-04-20 | 117 | 0 |
| K860571 | F.M. WEIST,KG (URODYNAMIC SYSTEMS) | F.M. Wiest USA, Inc. | 1986-03-18 | 32 | 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