Hermitage Hospital Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hermitage Hospital Products, Inc.” (first 1982, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 4 | 4 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Hermitage Hospital Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941802 | OR TOWEL | KKX | 1995-05-03 | 386 |
| K923115 | CLINISORB | NAB | 1992-11-23 | 151 |
| K923116 | COMBINE II WETPROOF PAD | NAB | 1992-10-06 | 103 |
| K891324 | HERMITEX SPONGE | NAB | 1989-04-27 | 45 |
| K863737 | SPONGES STERILE TWIN PAKT AND SINGLES | EFQ | 1986-10-14 | 21 |
| K843788 | CUSTOM BURN DRESSING KIT | KGN | 1984-11-07 | 41 |
| K822987 | DRESSING SPONGE | NAB | 1982-11-05 | 24 |
| K822623 | LAPAROTOMY SPONGE | GDY | 1982-10-13 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Hermitage Hospital Products, 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 Hermitage Hospital Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Hermitage Hospital Products, Inc.” (first 1982, latest 1995), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hermitage Hospital Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hermitage Hospital Products, Inc. is 44 days.
Which FDA product codes appear under Hermitage Hospital Products, Inc.?
The most frequent FDA product codes under this applicant name are NAB (Gauze / Sponge,Nonresorbable For External Use, 4); EFQ (Gauze/Sponge, Internal, 1); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 1).
Next steps
- See all 8 Hermitage Hospital Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAB, Hermitage Hospital Products, 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.