Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OUH · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
261 daysmedian FDA review time
379 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016-01-15 | 331 | 0 |
| K142833 | INTRAGen | Jeisys Medical, Inc. | 2015-06-04 | 247 | 0 |
| K130501 | INTENSIF | Endymed Medical, Ltd. | 2014-03-13 | 379 | 0 |
| K120513 | GLOW BY ENDYMED | Endymed Medical, Ltd. | 2012-05-08 | 77 | 0 |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Endymed Medical, Ltd. | 2011-02-17 | 261 | 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