Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPZ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912249 | PATIENT DOSE MONITOR | Theta Systems, Inc. | 1991-08-30 | 101 | 0 |
| K860469 | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS | Victoreen, Inc. | 1986-04-16 | 69 | 0 |
| K854410 | VERIFLEX | Old Delft Corp. of America | 1986-02-12 | 103 | 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