# K240077: Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 20, 2024 after 223 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874514 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874514: HI-LO Temp (R) General Purpose Temperature Probe, Mallinckrodt Critical Care (1988) Summary page 5.

## Indications for use
The Mon‑a‑Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

Source page: https://510kreport.com/device/K240077
Methodology: https://510kreport.com/methodology