Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FJF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
148 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904992 | MINNILERT AIR DETECTOR | Minntech Corp. | 1991-02-05 | 90 | 0 |
| K891327 | NICKLE-TITANIUM ORTHODONTIC WIRE | American Orthodontics | 1989-05-10 | 61 | 0 |
| K781330 | BLOOD LEVEL DETECTOR-MODEL 7601 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 | 29 | 0 |
| K780582 | DETECTOR, BUBBLE & FOAM | Hospal Medical Corp. | 1978-06-22 | 71 | 0 |
| K770857 | DIALYSIS MACHINE, CENTRY II | Cobe Laboratories, Inc. | 1977-10-04 | 148 | 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