Ear Thermometer, Models ST613C and ST613F
FDA 510(k) K011254 · Mesure Technology
510(k) numberK011254
Submission
- Device name
- Ear Thermometer, Models ST613C and ST613F
- Applicant
- Mesure Technology
Mission Viejo, CA, US - Received
- April 24, 2001
- Decision date
- July 10, 2001
- 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 |
| K013779 | Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and…FLL · Traditional | 03/29/2002SE |
| K011585 | Fast Thermometer Models ST713C and ST713FFLL · Traditional | 06/13/2001SE |
Questions and answers
When was Ear Thermometer, Models ST613C and ST613F cleared by the FDA?
Ear Thermometer, Models ST613C and ST613F (K011254) received a 510(k) decision of Substantially Equivalent on July 10, 2001, 77 days after the submission was received.
What is the product code of K011254?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.