Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hpi, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
333 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922116 | POWDER FREE NITRILE GLOVE | Hpi, Inc. | 1993-02-08 | 333 | 0 |
| K915086 | HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES | Hpi, Inc. | 1992-06-17 | 218 | 0 |
| K910383 | HPI SENSI-SHIELD GLOVE KIT | Hpi, Inc. | 1991-03-20 | 49 | 0 |
| K904878 | SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. | Hpi, Inc. | 1991-03-07 | 128 | 0 |
| K905086 | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES | Hpi, Inc. | 1990-12-03 | 19 | 0 |
| K901608 | HPI POWDER FREE NON-STERILE EXAMINATION GLOVES | Hpi, Inc. | 1990-04-20 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda