Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JYS · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860622 | STUDEX EAR PIERCING GUNS | Onyx Industries, Inc. | 1986-10-17 | 240 | 0 |
| K860678 | J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS | Jay Kenny Templeton | 1986-08-29 | 185 | 0 |
| K772171 | EAR PIERCING DEVICE | Robert C. Cameron | 1978-01-03 | 46 | 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