Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
El Global Trade, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
262 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | 2026-05-08 | 262 | 0 |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026-01-06 | 334 | 0 |
| K250384 | IPL400 | El Global Trade, Ltd. | 2025-05-23 | 101 | 0 |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | 2024-03-06 | 208 | 0 |
| K183260 | Sensilight Pro / Pistol IPL | El Global Trade, Ltd. | 2019-03-18 | 115 | 0 |
| K181095 | RF-Relief | El Global Trade, Ltd. | 2018-07-24 | 89 | 0 |
| K172181 | micro IPL | El Global Trade, Ltd. | 2017-10-13 | 86 | 0 |
| K170637 | sensiFirm | El Global Trade, Ltd. | 2017-07-14 | 134 | 0 |
| K170499 | sensiLift | El Global Trade, Ltd. | 2017-06-15 | 118 | 0 |
| K161089 | sensiLight Mini | El Global Trade, Ltd. | 2016-07-08 | 81 | 0 |
| K140381 | SENSILIGHT/ SENSILIGHT PLUS | El Global Trade, Ltd. | 2014-08-08 | 175 | 0 |
| K140527 | SENSILIGHT MINI | El Global Trade, Ltd. | 2014-07-31 | 149 | 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