Clini-Therm Corp.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Clini-Therm Corp.” (first 1984, latest 1984), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 176 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | 1 | 0 |
Review panels
- General Hospital (1)
- Radiology (1)
Most recent Clini-Therm Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833711 | THERMO SENTRY 1200 THERMO-SYS-TS1200 | FLL | 1984-04-13 | 176 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840015 | PMA | CLINI-THERM MARK I/IV | 1985-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Clini-Therm Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Clini-Therm Corp.?
FDA lists 1 510(k) clearance under the applicant name “Clini-Therm Corp.” (first 1984, latest 1984), plus 1 PMA decision, across 2 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 Clini-Therm Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clini-Therm Corp. is 176 days.
Which FDA product codes appear under Clini-Therm Corp.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 1); LOC (System, Rf/Microwave Hyperthermia, Cancer Treatment, 1).
Next steps
- See all 1 Clini-Therm Corp. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Clini-Therm Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.