# K152690: Disposable Thermometer Probe Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: Pinghu Sama Medical Packing Co., Ltd.
- Decided: Jan 15, 2016 after 116 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)
- K112289: Disposable Thermometer Covers and Sheaths, Kang ZE Industrial Co. Limited (2011) Summary page 4.

## Indications for use
The Disposable Thermometer Probe Sheaths are intended for use as barriers between digital thermometers and users' oral cavities to avoid the possible contamination and infection during temperature measuring. The sheaths are non-sterile and intended for single use only.

Source page: https://510kreport.com/device/K152690
Methodology: https://510kreport.com/methodology