Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JMA — 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) |
|---|---|---|---|---|---|
| K931523 | QUANTIMETRIX C-CLEAR(TM) | Quantimetrix Corp. | 1993-06-25 | 91 | 0 |
| K830978 | HELENA BIOSTRIP A | Helena Laboratories | 1983-05-13 | 45 | 0 |
| K822709 | URITEST 9, INLAB REAGENT STRIPS URINALY | Laprol Scientific, Inc. | 1983-01-28 | 143 | 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