Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JJB — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
280 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | Teco Diagnostics | 1995-04-24 | 280 | 0 |
| K943008 | BIOSCAN REAGENT STRIPS | Genesis Labs, Inc. | 1994-08-08 | 45 | 0 |
| K873553 | WAKO(TM) PRETEST 8A | Wako Chemicals USA, Inc. | 1987-09-22 | 25 | 0 |
| K862806 | URINE DIAGNOSTIC REAGENT STRIPS | Amatech International, Inc. | 1986-12-04 | 134 | 0 |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | Syn-Kit, Inc. | 1984-01-11 | 92 | 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