Model 1000 Electronic Clinical Thermometer
FDA 510(k) K885187 · Mon-A-Therm, Inc.
510(k) numberK885187
Submission
- Device name
- Model 1000 Electronic Clinical Thermometer
- Applicant
- Mon-A-Therm, Inc.
St. Louis, MO, US - Received
- December 14, 1988
- Decision date
- March 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K874522 | Modified Myocardial Temperature SensorKRB · Traditional | 01/29/1988SE |
| K874519 | Modified Esophageal Stethoscope/Temperature SensorBZW · Traditional | 01/29/1988SE |
| K875234 | Mon-A-Therm's Skin Temperature SensorFLL · Traditional | 01/19/1988SE |
| K874525 | Modified Foley Catheter/Temperature SensorKOD · Traditional | 01/06/1988SE |
| K874524 | Modified Subcutaneous Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874523 | Modified Tympanic & Esophageal/Rectal Temp. SensorFLL · Traditional | 01/06/1988SE |
| K874521 | Modified Thermal Well Temperature SensorFLL · Traditional | 01/06/1988SE |
| K874520 | Modified Airway Temperature SensorFLL · Traditional | 01/06/1988SE |
| K853392 | Mon-A-Therm Subcutaneous Temp. SensorFLL · Traditional | 11/22/1985SE |
| K830819 | Modification Electronic Clinical Thermo-FLL · Traditional | 04/06/1983SE |
Questions and answers
When was Model 1000 Electronic Clinical Thermometer cleared by the FDA?
Model 1000 Electronic Clinical Thermometer (K885187) received a 510(k) decision of Substantially Equivalent on March 8, 1989, 84 days after the submission was received.
What is the product code of K885187?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.