Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZF — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
118 daysmedian FDA review time
144 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Exmoor Plastics , Ltd. | 1998-01-23 | 123 | 0 |
| K862903 | MIDDLE EAR VIEWER AND FLUID COLLECTOR | Steven K. Juhn | 1986-11-24 | 116 | 0 |
| K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE | Downs Surgical , Ltd. | 1985-12-23 | 118 | 0 |
| K841357 | MICRO FLUID APPLICATOR | Treace Medical, Inc. | 1984-08-24 | 144 | 0 |
| K822010 | RIGID SUCTION TIPS & RELATED ITEMS | Kelleher Corp. | 1982-08-12 | 35 | 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