# K181967: Disposable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Launch Electrical Co., Ltd.
- Decided: Dec 10, 2018 after 140 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.
2 later devices descend from it; 1 cites it directly.
0 of 11 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
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (2020), 1 descendant of its own
- K223807: Reusable Temperature Probe, Disposable Temperature Probe (2023), 0 descendants of its own

## Indications for use
The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature. The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

Source page: https://510kreport.com/device/K181967
Methodology: https://510kreport.com/methodology
