YSI Model 790 Tele-Thermometer
by Yellow Springs Instrument Co., Inc. 510(k)
Active
510(k) K853551
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853551 | Date19 Sep 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 19 Sep 2026
The YSI Model 790 Tele-Thermometer is a medical device classified under product code FLL, intended for telemetric temperature measurement. It is designed to provide remote monitoring of body temperature, facilitating accurate and continuous thermal assessment in clinical settings.
This device is supplied as a reusable instrument and requires appropriate sterilization procedures between uses. It is not MRI-safe and must be used in environments where magnetic resonance imaging is not performed. The Model 790 holds an FDA 510(k) clearance under the General Hospital advisory committee, with a decision date of September 19, 1985.
Other devices from Yellow Springs Instrument Co., Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios would the YSI Model 790 Tele-Thermometer be useful for, and how does its telemetric design improve patient monitoring?
The YSI Model 790 Tele-Thermometer is designed for remote, continuous monitoring of body temperature, making it ideal for clinical settings where real-time thermal assessment is critical. Its telemetric capability allows healthcare providers to track temperature without direct physical contact, reducing disruption to patients—particularly beneficial in intensive care, postoperative recovery, or long-term monitoring scenarios. This feature also minimizes the risk of cross-contamination compared to traditional contact-based thermometers.
How should the YSI Model 790 Tele-Thermometer be prepared for reuse between patients, and what sterilization methods are recommended?
Since the YSI Model 790 is a reusable device, it must undergo proper sterilization between uses to ensure patient safety. While the manufacturer does not specify exact methods in the provided data, standard sterilization techniques such as autoclaving, ethylene oxide gas, or chemical sterilization (e.g., hydrogen peroxide vapor) are typically used for reusable medical devices of this type. Always follow the manufacturer’s instructions or validated protocols in your facility to maintain sterility and functionality.
Is the YSI Model 790 Tele-Thermometer compatible with MRI environments, and why might this limitation matter?
No, the YSI Model 790 Tele-Thermometer is explicitly not MRI-safe, meaning it should never be used in or near magnetic resonance imaging (MRI) equipment. This limitation matters because MRI environments generate strong magnetic fields that can interfere with or damage non-MRI-safe devices, posing risks to both the device and patients. Clinicians should ensure the device is only used in non-MRI areas to avoid operational failures or safety hazards.
What regulatory pathway was followed for FDA clearance of the YSI Model 790 Tele-Thermometer, and what does ‘Substantially Equivalent’ mean in this context?
The YSI Model 790 Tele-Thermometer received FDA clearance through a 510(k) premarket notification, filed under the General Hospital advisory committee (product code FLL) on August 26, 1985. The clearance was granted as ‘Substantially Equivalent’ (SESE), meaning the FDA determined that the device is as safe and effective as a legally marketed predicate device already on the market. This classification streamlines approval by demonstrating that the new device does not present unreasonable risks compared to existing solutions.