Hospital Products Co.: FDA clearances and approvals
Hospital Products Co. has 6 FDA 510(k) clearances (first 1979, latest 1983), across 6 product codes in 4 review panels. Median 510(k) review time: 18 days.
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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | 1 | 1 |
| KRA | Catheter, Continuous Flush | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Hospital Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823696 | MICRO Z BLOOD COLLECTING NEEDLES | FMI | 1983-01-26 | 49 |
| K810318 | PARKE-DAVIS NON-WOVEN SPONGE | NAB | 1981-02-26 | 20 |
| K801602 | DESERET I.V. FILTER | FPB | 1980-08-27 | 44 |
| K801173 | ANGIO-FLO MONITORING KIT | KRA | 1980-05-28 | 12 |
| K792386 | NUTRA-PH INSTRUMENT MILK | — | 1979-12-10 | 14 |
| K791350 | POPE AMBULATORY HALO VEST | IQF | 1979-08-03 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Hospital Products Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hospital Products Co. have?
Hospital Products Co. has 6 FDA 510(k) clearances (first 1979, latest 1983), across 6 product codes in 4 review panels.
How long does FDA take to clear Hospital Products Co.'s 510(k)s?
The median time from FDA receipt to decision across Hospital Products Co.'s cleared 510(k)s is 18 days.
What devices does Hospital Products Co. make?
Its most frequent FDA product codes are FMI (Needle, Hypodermic, Single Lumen, 1); FPB (Filter, Infusion Line, 1); IQF (Orthosis, Cervical-Thoracic, Rigid, 1).
Has Hospital Products Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hospital Products Co. Related entities may recall under other names.
Next steps
- See all 6 Hospital Products Co. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Hospital Products Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.