Hospital Specialty Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hospital Specialty Co.” (first 1982, latest 1999), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | 2 | 2 |
| HHD | Pad, Menstrual, Unscented | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
Most recent Hospital Specialty Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | NAD | 1999-04-12 | 27 |
| K941099 | CLEAN-SORB | EFQ | 1994-09-30 | 207 |
| K882094 | GARDS DEODORANT SANITARY NAPKIN | HHL | 1988-09-22 | 126 |
| K880454 | AT EASE STRESS PAD | EYQ | 1988-06-16 | 135 |
| K880455 | AT EASE ADULT DIAPER | EYQ | 1988-04-14 | 72 |
| K822242 | SANITARY/OB NAPKINS | HHD | 1982-09-09 | 44 |
| K822433 | GARDS (UNSCENTED, MENSTRUAL PAD) | HHD | 1982-08-30 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Hospital Specialty Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hospital Products Co. (6 510(k)s)
- Hospital Disposables, Inc. (3 510(k)s)
- Hospital For Special Surgery (3 510(k)s)
- Hospital Concepts, Inc. (2 510(k)s)
- Hospital Equipment Service (2 510(k)s)
- Hospital Supply Co., Inc. (2 510(k)s)
- Hospital Equipment Manufacturing Company (1 510(k)s)
- Hospital Financial Corp. (1 510(k)s)
- Hospital Laundry Services (1 510(k)s)
- Hospital Marketing Services Co., Inc. (1 510(k)s)
- Hospital Products Group (1 510(k)s)
- Hospital Products Intl. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hospital Specialty Co.?
FDA lists 7 510(k) clearances under the applicant name “Hospital Specialty Co.” (first 1982, latest 1999), across 5 product codes in 3 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 Hospital Specialty Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hospital Specialty Co. is 72 days.
Which FDA product codes appear under Hospital Specialty Co.?
The most frequent FDA product codes under this applicant name are EYQ (Garment, Protective, For Incontinence, 2); HHD (Pad, Menstrual, Unscented, 2); EFQ (Gauze/Sponge, Internal, 1).
Next steps
- See all 7 Hospital Specialty Co. clearances with predicates and recalls
- Run predicate analysis for product code EYQ, Hospital Specialty Co.'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.