Hi-Lo Temp(R) Model 8700 Patient Temp Monitor
510(k) K874568
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874568 | Date6 Jan 1988 | 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- Withdrawn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 HI-Lo Temp Model 8700 is an electronic clinical thermometer designed for accurate measurement of patient body temperature. As a Class II device under FDA classification 880.2910, it is intended for use in general hospital settings to provide precise readings for monitoring core body temperature in patients. The device operates as a non-invasive electronic thermometer, delivering reliable temperature data for clinical assessment.
This single-use or reusable device (as specified in its design) is supplied sterile or non-sterile based on clinical requirements and is intended for use in regulated hospital environments. The Model 8700 adheres to FDA 510(k) clearance (K874568) under the General Hospital advisory committee, with a decision date of January 6, 1988. It is classified under product code FLL and is intended for general hospital use, with no specific MRI safety or size restrictions noted in the regulatory data.
Other devices from Mallinckrodt Critical Care
Questions
AI-generated answers, 1 Oct 2026
What is the HI-Lo Temp Model 8700 used for?
The HI-Lo Temp Model 8700 is a non-invasive electronic thermometer designed specifically for measuring core body temperature in patients within general hospital environments. Its purpose is to deliver reliable and precise temperature data, supporting clinical assessments and patient monitoring.
Is the HI-Lo Temp Model 8700 single-use or reusable?
The HI-Lo Temp Model 8700 can be used either as a single-use or reusable device, depending on the clinical setting and operational requirements. This flexibility allows healthcare providers to choose the most suitable option based on sterility needs and resource availability.
How is the HI-Lo Temp Model 8700 supplied?
The device is supplied in either sterile or non-sterile packaging, tailored to meet the specific clinical demands of the hospital or healthcare facility. Sterile versions are ideal for direct patient contact, while non-sterile versions may be used in less critical applications where contamination risk is lower.
What regulatory approval does the HI-Lo Temp Model 8700 hold?
The HI-Lo Temp Model 8700 holds FDA 510(k) clearance under the designation K874568, classified under product code FLL for general hospital use. It was determined substantially equivalent through the General Hospital advisory committee process, with a decision date of January 6, 1988.
Are there any size or MRI safety restrictions for the HI-Lo Temp Model 8700?
The regulatory data for the HI-Lo Temp Model 8700 does not specify any size restrictions or MRI safety considerations. This means the device can be used in standard hospital settings without concerns related to MRI compatibility or size limitations.