Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JYL — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
106 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834188 | JAKOBI SURG. INSTRUMENTS #7 10/43 | Imm Enterprises , Ltd. | 1984-03-06 | 106 | 0 |
| K822195 | MIRCOSURGICAL INSTRUMENTS | Kelleher Corp. | 1982-08-25 | 33 | 0 |
| K822166 | MICROSURGICAL EAR HOOK | Kelleher Corp. | 1982-08-20 | 28 | 0 |
| K780287 | DAY HEAR HOOK | Edward Weck, Inc. | 1978-02-27 | 6 | 0 |
| K772390 | DAY EAR HOOK | Edward Weck, Inc. | 1978-01-17 | 21 | 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