# K212945: Sterile Disposable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Envisen Industry Co., Ltd.
- Decided: Mar 1, 2022 after 167 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: 2 generations back to K925791 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200631: DeRoyal Temperature Monitoring Probe, Deroyal Industries, Inc. (2020) Summary page 4.

## Indications for use
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.

Source page: https://510kreport.com/device/K212945
Methodology: https://510kreport.com/methodology