Hpi, Inc.: FDA clearances and approvals
Hpi, Inc. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time: 88 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 3 | 3 |
| IWP | Radiographic Protective Glove | 2 | 2 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (4)
- Radiology (2)
Most recent Hpi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922116 | POWDER FREE NITRILE GLOVE | KGO | 1993-02-08 | 333 |
| K915086 | HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES | KGO | 1992-06-17 | 218 |
| K910383 | HPI SENSI-SHIELD GLOVE KIT | KGO | 1991-03-20 | 49 |
| K904878 | SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. | IWP | 1991-03-07 | 128 |
| K905086 | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES | IWP | 1990-12-03 | 19 |
| K901608 | HPI POWDER FREE NON-STERILE EXAMINATION GLOVES | LYY | 1990-04-20 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Hpi, Inc..
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 Hpi, Inc. have?
Hpi, Inc. has 6 FDA 510(k) clearances (first 1990, latest 1993), across 3 product codes in 2 review panels.
How long does FDA take to clear Hpi, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hpi, Inc.'s cleared 510(k)s is 88 days.
What devices does Hpi, Inc. make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 3); IWP (Radiographic Protective Glove, 2); LYY (Latex Patient Examination Glove, 1).
Has Hpi, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hpi, Inc. Related entities may recall under other names.
Next steps
- See all 6 Hpi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Hpi, Inc.'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.