# K061007: Good Medy,  Disposable Thermometer Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: Good Medy Enterprise, Ltd.
- Decided: Jun 14, 2006 after 64 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 K871465 (1987). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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 1.

## Most influential descendants
- K102508: YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 (2011), 2 descendants of its own
- K112289: Disposable Thermometer Covers and Sheaths (2011), 1 descendant of its own
- 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 (2021), 0 descendants of its own
- K180714: Probe Covers for Thermometers (2018), 0 descendants of its own
- K152690: Disposable Thermometer Probe Sheaths (2016), 0 descendants of its own

## Indications for use
The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.

Source page: https://510kreport.com/device/K061007
Methodology: https://510kreport.com/methodology