Thermocouple Sensors, Access. for Electronic Therm
510(k) K844056
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844056 | Date9 Jan 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The device is a thermocouple sensor, a type of temperature-measuring probe designed to interface with electronic thermometers. Thermocouples generate a voltage proportional to temperature differences between two dissimilar metal junctions, enabling precise readings in clinical settings. These sensors are commonly used in medical applications to monitor body temperature accurately and efficiently. Their compact and reusable design supports integration with various electronic thermometer systems.
These thermocouple sensors are intended for use as accessories in electronic thermometer systems, facilitating temperature measurement in general hospital environments. Supplied as reusable devices, they require proper cleaning and maintenance to ensure accuracy and sterility. The product holds FDA 510(k) clearance (K844056) under the General Hospital advisory committee classification, adhering to regulatory standards for medical temperature-sensing devices. No specific sterility or single-use designation is noted in the data.
Other devices from Sensortek, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are these thermocouple sensors used for in clinical settings?
These thermocouple sensors are designed as accessories for electronic thermometer systems to measure body temperature accurately. They generate a voltage proportional to temperature differences between two metal junctions, providing precise readings essential for patient monitoring in general hospital environments. Their compact and reusable design ensures compatibility with various electronic thermometer platforms.
Are these sensors single-use or reusable, and what maintenance is required?
These thermocouple sensors are reusable, not single-use. To maintain accuracy and sterility, they require proper cleaning and routine maintenance as part of their design. Regular upkeep ensures reliable performance over extended use in clinical settings.
How do I know if these sensors meet regulatory standards?
These sensors hold FDA 510(k) clearance (K844056) under the General Hospital advisory committee classification, confirming they meet regulatory standards for medical temperature-sensing devices. The clearance indicates they are deemed substantially equivalent to a legally marketed device.
What is the advisory committee classification for this device?
The device falls under the General Hospital advisory committee classification (HO), specifically categorized under product code FLL. This classification is used for medical devices intended for use in general hospital settings, including temperature monitoring accessories.
Can these sensors be used with any electronic thermometer system?
These thermocouple sensors are designed as accessories for electronic thermometer systems, but compatibility depends on the specific system’s design and interface requirements. While they are versatile for general hospital use, verifying compatibility with your thermometer model is recommended to ensure proper function.