# K202009: Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Juzhong Technology Co., Ltd.
- Decided: Mar 22, 2021 after 244 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 5.

## Indications for use
The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.

Source page: https://510kreport.com/device/K202009
Methodology: https://510kreport.com/methodology