# K180714: Probe Covers for Thermometers

- Pathway: 510(k) (Abbreviated)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Sep 24, 2018 after 189 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 K871465 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102508: YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02, Yu Long Sheng Technology Co., Ltd. (2011) Summary page 4.

## Indications for use
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.

Source page: https://510kreport.com/device/K180714
Methodology: https://510kreport.com/methodology