Termosalud: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Termosalud” (first 2023, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 64 days. Since 2017 the median was 64 days, against 92 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 3 | 64 |
| 2024 | 1 | 63 |
| 2025 | 1 | 86 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Termosalud took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | 2 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
Review panels
Most recent Termosalud 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243488 | VMAT PRO | ISA | 2025-02-06 | 86 |
| K241656 | Eneka Selectif | GEX | 2024-08-12 | 63 |
| K230659 | Zionic Aesthetic | PBX | 2023-06-08 | 91 |
| K230412 | Symmed Elite Aesthetic | PBX | 2023-04-13 | 57 |
| K223680 | Eneka Pro | GEX | 2023-02-10 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Termosalud.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Termosalud S.L. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Termosalud?
FDA lists 5 510(k) clearances under the applicant name “Termosalud” (first 2023, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Termosalud?
The median time from FDA receipt to decision across 510(k)s cleared under the name Termosalud is 64 days. Since 2017: 64 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Termosalud?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 2); ISA (Massager, Therapeutic, Electric, 1).
Next steps
- See all 5 Termosalud clearances with predicates and recalls
- Run predicate analysis for product code GEX, Termosalud's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.