Escort II Clinical Thermometry Module (CTM)
FDA 510(k) K970011 · Medical Data Electronics
510(k) numberK970011
Submission
- Device name
- Escort II Clinical Thermometry Module (CTM)
- Applicant
- Medical Data Electronics
Arleta, CA, US - Received
- January 2, 1997
- Decision date
- July 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K014294 | Modification to Escort Ii+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401…DQA · Special | 01/25/2002SE |
| K012336 | Modification To:Escort Vision Central Station Telemetry System, Model 20500DSI · Special | 10/03/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | 03/28/2000SE |
| K992413 | Escort 100/300 Series B (Escort II) Patient MonitorDRT · Special | 08/19/1999SE |
| K992411 | Escort Ii+ 400 Series (Escort Prism) MonitorDRT · Special | 08/18/1999SE |
| K982104 | Escort-Link Central Station Monitor Model 20500MLD · Special | 11/25/1998SE |
| K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorDQA · Traditional | 07/14/1997SE |
| K970012 | Escort Link Central Station MonitorDSI · Traditional | 06/26/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | 12/10/1996SE |
| K943256 | Cardiac Output Option 39DXG · Traditional | 12/15/1994SE |
Questions and answers
When was Escort II Clinical Thermometry Module (CTM) cleared by the FDA?
Escort II Clinical Thermometry Module (CTM) (K970011) received a 510(k) decision of Substantially Equivalent on July 9, 1997, 188 days after the submission was received.
What is the product code of K970011?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.