Classic/Hypothermia, Flexible, 10-SECOND, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer
FDA 510(k) K070028 · Actherm, Inc.
510(k) numberK070028
Submission
- Device name
- Classic/Hypothermia, Flexible, 10-SECOND, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer
- Applicant
- Actherm, Inc.
Jubei, Hsinchu, TW - Received
- January 3, 2007
- Decision date
- February 8, 2007
- 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 |
|---|---|---|
| K093795 | Actherm Infrared Ear Thermometer Act 8000R Series and Its Probe Cover Med ACCU2010FLL · Special | 03/12/2010SE |
| 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 |
| 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 Classic/Hypothermia, Flexible, 10-SECOND, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer cleared by the FDA?
Classic/Hypothermia, Flexible, 10-SECOND, Left-Right Handed, Basal, Lightweight-Probe Digital Clinical Thermometer (K070028) received a 510(k) decision of Substantially Equivalent on February 8, 2007, 36 days after the submission was received.
What is the product code of K070028?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.