# K182755: Disposable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Caremed Medical Technology Co., Ltd.
- Decided: Dec 21, 2018 after 84 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: 3 generations back to K962070 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121999: General Purpose Temperature Probe, Skin Temperature Probe, Draeger Medical GmbH (2013) Summary page 4.

## Most influential descendants
- K193625: Disposable Temperature Probe (2020), 0 descendants of its own

## Indications for use
Rectal Temperature Probe: The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only. Skin Temperature Probe: The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K182755
Methodology: https://510kreport.com/methodology