# K251160: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jan 8, 2026 after 268 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 6.

## Indications for use
The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel. The probe is offered in the following three configurations: - Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity. - Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient's skin surface. - Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult's auditory canal. For pediatric population, the subpopulations are children and adolescents.

Source page: https://510kreport.com/device/K251160
Methodology: https://510kreport.com/methodology