Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IWP — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
128 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920538 | PROTECTIVE RADIOGRAFIC GLOVE | Burkhart Roentgen Intl., Inc. | 1992-05-29 | 114 | 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 |
| K900972 | RADIATION PROTECTION GLOVES | Infab Corp. | 1990-05-01 | 60 | 0 |
| K844683 | IMAGEN CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1985-02-06 | 68 | 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