Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKJ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
149 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | Serim Research | 2026-03-17 | 104 | 0 |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Serim Research Corp. | 1990-09-13 | 149 | 0 |
| K841307 | BBL GASPAK POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 | 45 | 0 |
| K820575 | J.E.T. DIALYSIS SYSTEM | Computer Dialysis Systems, Inc. | 1982-05-20 | 78 | 0 |
| K772040 | TRANSDUCER PROTECTOR | Terumo America, Inc. | 1977-11-28 | 31 | 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