IVAC 819 Electronic Thermometer
by Y 510(k)
Active
510(k) K791209
Overview
The IVAC 819 Electronic Thermometer is a continuous measurement thermometer designed for accurate and real-time monitoring of body temperature. Classified under product code FLL, it is intended for use in general hospital settings to provide precise temperature readings, aiding in patient assessment and clinical decision-making.
This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the traditional review pathway, with a decision of Substantially Equivalent (SESE). It was submitted to the FDA in July 1979 and cleared in August 1979, falling under the classification of Class II – Special Controls. No additional regulatory details regarding sterility, MRI safety, or specific storage conditions are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791209 | Date3 Aug 1979 | 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- Withdrawn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 Y
Questions
What is the IVAC 819 Electronic Thermometer used for?
The IVAC 819 Electronic Thermometer is designed for continuous, real-time monitoring of body temperature in general hospital settings. Its primary purpose is to provide accurate and precise temperature readings, which support patient assessment and help clinicians make informed clinical decisions. This is particularly useful in environments where ongoing temperature tracking is critical, such as intensive care or post-operative recovery.
Is the IVAC 819 Electronic Thermometer reusable or single-use?
The IVAC 819 Electronic Thermometer is supplied as a reusable medical instrument. Reusability is advantageous in hospital settings as it reduces waste and can lower costs over time, provided proper cleaning, maintenance, and sterilization protocols are followed. The device’s design aligns with traditional reusable medical equipment standards, ensuring durability and repeated use across multiple patients.
What regulatory pathway was followed for the IVAC 819 Electronic Thermometer?
The IVAC 819 Electronic Thermometer underwent the traditional review pathway for FDA clearance, receiving a decision classified as Substantially Equivalent (SESE). This pathway involves a detailed evaluation by the FDA to ensure the device meets established performance standards and safety requirements. The clearance was granted in August 1979, confirming its compliance with Class II – Special Controls under product code FLL.
Where was the IVAC 819 Electronic Thermometer submitted and cleared by the FDA?
The device was submitted to the FDA’s office in Mchenry, Illinois (address: 803 N. Front St. Suite 3), and received clearance under K-number K791209. The submission was reviewed by the Hospital Devices (HO) Advisory Committee, reflecting its intended use in general hospital environments. This regulatory filing process ensures the device adheres to safety and effectiveness standards for its designated clinical applications.
Are there any specific storage or handling instructions for the IVAC 819 Electronic Thermometer?
While the provided data does not specify detailed storage conditions, reusable medical devices like the IVAC 819 generally require proper handling to maintain functionality and hygiene. This includes storing the device in a clean, dry environment away from direct sunlight or extreme temperatures, following manufacturer guidelines for cleaning and disinfection, and ensuring it is stored in a manner that prevents contamination or damage. Adhering to these practices extends the device’s lifespan and ensures reliable performance.