# K203431: Disposable Ear Thermometer Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Huaian Zhongxin Packing Material Co., Ltd.
- Decided: Jul 28, 2021 after 247 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: 2 generations back to K031928 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101747: Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 SE, Kaz USA, Inc (A Subsidiaryof Kaz Inc) (2010) Summary page 5.

## Indications for use
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.

Source page: https://510kreport.com/device/K203431
Methodology: https://510kreport.com/methodology