# K173113: Medline Disposable Electronic Thermometer Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 17, 2018 after 110 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: 1 generation back to K030580 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030580: Suretemp Plus, Welch Allyn, Inc. (2003) Summary page 4.

## Indications for use
The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.

Source page: https://510kreport.com/device/K173113
Methodology: https://510kreport.com/methodology