Actherm, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Actherm, Inc.” (first 2001, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 26 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 | 8 | 8 |
Review panels
- General Hospital (8)
Most recent Actherm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093795 | ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 | FLL | 2010-03-12 | 92 |
| K083419 | ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 | FLL | 2009-07-16 | 239 |
| K090031 | ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 | FLL | 2009-04-16 | 101 |
| K070028 | CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER | FLL | 2007-02-08 | 36 |
| K031905 | DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 | FLL | 2003-07-07 | 17 |
| K021614 | DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 | FLL | 2002-05-30 | 14 |
| K021612 | DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 | FLL | 2002-05-30 | 14 |
| K010238 | ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ | FLL | 2001-02-06 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Actherm, Inc..
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 Actherm, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Actherm, Inc.” (first 2001, latest 2010), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Actherm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Actherm, Inc. is 26 days.
Which FDA product codes appear under Actherm, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 8).
Next steps
- See all 8 Actherm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Actherm, Inc.'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.