# K112289: Disposable Thermometer Covers and Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: Kang ZE Industrial Co. Limited
- Decided: Dec 16, 2011 after 129 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 K871465 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for, Banta Healthcare Group, Ltd. (1998) Summary page 2.
- K061007: Good Medy,  Disposable Thermometer Sheaths, Good Medy Enterprise, Ltd. (2006) Summary page 2.

## Most influential descendants
- K152690: Disposable Thermometer Probe Sheaths (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K112289
Methodology: https://510kreport.com/methodology