Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neward Enterprises, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
264 daysmedian FDA review time
339 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1996-08-29 | 203 | 0 |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1995-05-03 | 264 | 0 |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | Neward Enterprises, Inc. | 1994-05-04 | 260 | 0 |
| K925572 | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE | Neward Enterprises, Inc. | 1993-10-08 | 339 | 0 |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Neward Enterprises, Inc. | 1992-06-22 | 333 | 0 |
| K910815 | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | 1991-12-10 | 287 | 0 |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1989-03-31 | 67 | 0 |
| K840403 | VENA * BRIDGE | Neward Enterprises, Inc. | 1984-03-12 | 41 | 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