# K193625: Disposable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
- Decided: Jul 24, 2020 after 211 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: 4 generations back to K962070 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182755: Disposable Temperature Probe, Shenzhen Caremed Medical Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours. The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.

Source page: https://510kreport.com/device/K193625
Methodology: https://510kreport.com/methodology