Mcneil Healthcare, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Mcneil Healthcare, Inc.” (first 1994, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 14 | 14 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 5 | 5 |
Review panels
Most recent Mcneil Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935930 | NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING | EFQ | 1994-02-03 | 52 |
| K935883 | NEUROLOGICAL SPONGES | GDY | 1994-02-03 | 56 |
| K935993 | SURGICAL SPONGE X-RAY DETECTABLE | GDY | 1994-02-02 | 51 |
| K935934 | NON ADHERANT BURN PADS | EFQ | 1994-01-31 | 49 |
| K935911 | PACKING SPONGE | EFQ | 1994-01-31 | 53 |
| K935910 | X-RAY PACKING SPONGE | GDY | 1994-01-31 | 53 |
| K935882 | TONSIL SPONGES | GDY | 1994-01-31 | 53 |
| K935881 | SPECIALTY SPONGES | GDY | 1994-01-31 | 53 |
| K935941 | READY CUT GAUZE GAUZE BOLTS | EFQ | 1994-01-14 | 32 |
| K935940 | GAUZE SPONGE; DRAIN SPONGE | EFQ | 1994-01-14 | 32 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mcneil Healthcare, 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 Mcneil Healthcare, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Mcneil Healthcare, Inc.” (first 1994, latest 1994), across 2 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 Mcneil Healthcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mcneil Healthcare, Inc. is 32 days.
Which FDA product codes appear under Mcneil Healthcare, Inc.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 14); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 5).
Next steps
- See all 19 Mcneil Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Mcneil Healthcare, 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.