Neward Enterprises, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Neward Enterprises, Inc.” (first 1984, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 262 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | 5 | 5 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Neward Enterprises, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | HDB | 1996-08-29 | 203 |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | HDB | 1995-05-03 | 264 |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | HDB | 1994-05-04 | 260 |
| K925572 | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE | HGM | 1993-10-08 | 339 |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | HDB | 1992-06-22 | 333 |
| K910815 | CR SPIRAL ELECTRODE | HGP | 1991-12-10 | 287 |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | HDB | 1989-03-31 | 67 |
| K840403 | VENA * BRIDGE | — | 1984-03-12 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Neward Enterprises, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neward Enterprises, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Neward Enterprises, Inc.” (first 1984, latest 1996), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neward Enterprises, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neward Enterprises, Inc. is 262 days.
Which FDA product codes appear under Neward Enterprises, Inc.?
The most frequent FDA product codes under this applicant name are HDB (Extractor, Vacuum, Fetal, 5); HGM (System, Monitoring, Perinatal, 1); HGP (Electrode, Circular (Spiral), Scalp And Applicator, 1).
Next steps
- See all 8 Neward Enterprises, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HDB, Neward Enterprises, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.