Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PAY — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
261 daysmedian FDA review time
439 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026-01-06 | 334 | 0 |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | 2025-10-12 | 439 | 0 |
| K240616 | FAQ™ (102) | Foreo, Inc. | 2024-07-15 | 132 | 0 |
| K233766 | Geneo X Elite | Pollogen, Ltd. | 2024-05-07 | 165 | 0 |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | 2024-03-06 | 208 | 0 |
| K230013 | Silk'n Titan Allways | Silk'N Beauty , Ltd. | 2023-08-30 | 239 | 0 |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023-05-04 | 455 | 0 |
| K222012 | FAQ 101 | Foreo, Inc. | 2023-04-05 | 271 | 0 |
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021-02-25 | 71 | 0 |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019-06-19 | 261 | 0 |
| K170499 | sensiLift | El Global Trade, Ltd. | 2017-06-15 | 118 | 0 |
| DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | 2015-12-18 | 336 | 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