Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010
FDA 510(k) K093795 · Actherm, Inc.
510(k) numberK093795
Submission
- Device name
- Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010
- Applicant
- Actherm, Inc.
Hsinchu, TW - Received
- December 10, 2009
- Decision date
- March 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLL – Continuous Measurement Thermometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2910
- Specialty
- General Hospital
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Other 510(k)s with product code FLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | Unimed Medical Supplies, Inc. | 06/05/2026SE |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 01/08/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 06/23/2025SE |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional | Shenzhen Medke Technology Co., Ltd. | 06/20/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 05/22/2025SE |
| K243082 | Infrared ThermometerFLL · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 04/25/2025SE |
| K250401 | AION TempShieldFLL · Traditional | Aion Biosystems, Inc. | 03/14/2025SE |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional | Shenzhen Finicare Co., Ltd. | 02/14/2025SE |
| K240333 | Wearable Digital Thermometer (T31)FLL · Traditional | Guangdong Genial Technology Co., Ltd. | 10/30/2024SE |
| K240223 | FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional | Metko Medikal VE Tibbi Cihazlar Dis Ticaret… | 10/25/2024SE |
More from Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
| 510(k) | Device | Decision |
|---|---|---|
| K083419 | Actherm Digital Clinical Thermometer Probe Covers, Model(S) MEDACCU1010, MEDACCU1010-1…FLL · Traditional | 07/16/2009SE |
| K090031 | Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover for Actherm Infrared Ear…FLL · Traditional | 04/16/2009SE |
| K070028 | Classic/Hypothermia, Flexible, 10-SECOND, Left-Right Handed, Basal, Lightweight-Probe…FLL · Special | 02/08/2007SE |
| K031905 | Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, and Act 3030FLL · Special | 07/07/2003SE |
| K021614 | Digital Clinical Thermometer, Model Act 3020FLL · Special | 05/30/2002SE |
| K021612 | Digital Clinical Thermometer, Models Act 2030, 2038FLL · Special | 05/30/2002SE |
| K010238 | Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+…FLL · Traditional | 02/06/2001SE |
Questions and answers
When was Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010 cleared by the FDA?
Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010 (K093795) received a 510(k) decision of Substantially Equivalent on March 12, 2010, 92 days after the submission was received.
What is the product code of K093795?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.