Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Termosalud — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
91 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | 2025-02-06 | 86 | 0 |
| K241656 | Eneka Selectif | Termosalud | 2024-08-12 | 63 | 0 |
| K230659 | Zionic Aesthetic | Termosalud | 2023-06-08 | 91 | 0 |
| K230412 | Symmed Elite Aesthetic | Termosalud | 2023-04-13 | 57 | 0 |
| K223680 | Eneka Pro | Termosalud | 2023-02-10 | 64 | 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