Check Mate #1850 Elec. Digital Thermo
by Bristoline, Inc. 510(k)
Active
510(k) K823493
Overview
The Check Mate #1850 Electronic Digital Thermometer is a clinical electronic thermometer designed to measure body temperature. It features a transducer in a detachable probe, coupled with an electronic signal amplification, conditioning, and display unit for accurate readings.
This device is intended for single-use or reusable applications in general hospital settings, as indicated by its FDA 510(k) clearance under product code FLL. Supplied sterile or non-sterile based on clinical requirements, it adheres to regulatory standards for electronic clinical thermometers. The device is authorized for use in the United States under the Traditional 510(k) pathway, with no third-party review involved.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823493 | Date28 Feb 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bristoline, Inc.
Questions
Is the Check Mate #1850 Electronic Digital Thermometer designed for single-use only, or can it be reused after cleaning and sterilization?
The Check Mate #1850 is approved for both single-use and reusable applications in general hospital settings. Since it is cleared under product code FLL (which includes reusable clinical thermometers), it can be reused if properly cleaned and sterilized between uses. The manufacturer’s instructions should specify any required reprocessing protocols.
How is the Check Mate #1850 Electronic Digital Thermometer supplied—does it come sterile, or is it non-sterile by default?
The device is supplied either sterile or non-sterile, depending on clinical requirements. The packaging instructions (likely provided by Bristoline, Inc.) will indicate whether a specific lot is sterile or not, as this is determined by the user’s needs rather than a fixed default.
What does the FDA clearance under product code FLL mean for how this thermometer can be used in a hospital?
The FLL product code indicates the Check Mate #1850 is cleared for use in general hospital settings to measure body temperature. This includes both inpatient and outpatient environments where electronic thermometers are standard. The clearance does not restrict use to specific patient types or procedures—only that it complies with FDA standards for clinical thermometry.
Does the Check Mate #1850 require any special storage conditions, or can it be stored at room temperature?
The device’s specifications do not mention special storage requirements beyond typical environmental conditions for electronic medical devices. However, to ensure accuracy and longevity, it should be stored in a clean, dry place away from extreme temperatures or humidity, following the manufacturer’s guidelines. If reusable, probes should be stored in a manner that prevents contamination.