Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F
FDA 510(k) K013779 · Mesure Technology
510(k) numberK013779
Submission
- Device name
- Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F
- Applicant
- Mesure Technology
Acton, CA, US - Received
- November 13, 2001
- Decision date
- March 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K080981 | Ear Thermometer, Models ST66 and ST67FLL · Special | 05/02/2008SE |
| K071019 | Digital Clinical Thermometer/Models ST8C SeriesFLL · Special | 04/27/2007SE |
| K063542 | Wireless Temperature Monitor / Models ST323C and ST323F.FLL · Traditional | 04/10/2007SE |
| K050303 | 5 Sec Digital Clinical Thermometer, Models ST8630X, ST8640X, ST8730X, ST8740X, ST8930X…FLL · Special | 02/25/2005SE |
| K042627 | Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65FLL · Special | 10/18/2004SE |
| K042013 | Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FFLL · Special | 09/08/2004SE |
| K023956 | Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/FFLL · Traditional | 06/17/2004SE |
| K041056 | 10-SECOND Digital Thermometer, Models ST87, ST89, ST80, ST88FLL · Special | 05/12/2004SE |
| K011254 | Ear Thermometer, Models ST613C and ST613FFLL · Traditional | 07/10/2001SE |
| K011585 | Fast Thermometer Models ST713C and ST713FFLL · Traditional | 06/13/2001SE |
Questions and answers
When was Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F cleared by the FDA?
Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F (K013779) received a 510(k) decision of Substantially Equivalent on March 29, 2002, 136 days after the submission was received.
What is the product code of K013779?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.