International Hospital Supply Co.: FDA clearances and approvals
International Hospital Supply Co. has 5 FDA 510(k) clearances (first 1991, latest 2004), across 5 product codes in 4 review panels. Median 510(k) review time: 79 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
- General Hospital (2)
- Neurology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent International Hospital Supply Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040853 | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 | LBI | 2004-06-21 | 81 |
| K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS | FMT | 2003-12-17 | 79 |
| K911982 | BONE NAIL, KUNTSCHER | HSD | 1991-07-26 | 84 |
| K911377 | FORCEPS, COAGULATION, BIPOLAR, MALIS | GEI | 1991-04-19 | 22 |
| K910621 | BLADES FOR SPINAL LAMINECTOMY RETRACTOR | GZT | 1991-04-01 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named International Hospital Supply 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 International Hospital Supply Co. have?
International Hospital Supply Co. has 5 FDA 510(k) clearances (first 1991, latest 2004), across 5 product codes in 4 review panels.
How long does FDA take to clear International Hospital Supply Co.'s 510(k)s?
The median time from FDA receipt to decision across International Hospital Supply Co.'s cleared 510(k)s is 79 days.
What devices does International Hospital Supply Co. make?
Its most frequent FDA product codes are FMT (Warmer, Infant Radiant, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); GZT (Retractor, Self-Retaining, For Neurosurgery, 1).
Has International Hospital Supply Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching International Hospital Supply Co. Related entities may recall under other names.
Next steps
- See all 5 International Hospital Supply Co. clearances with predicates and recalls
- Run predicate analysis for product code FMT, International Hospital Supply 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.