# K183431: Medline Digital Rectal Thermometer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 14, 2019 after 185 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 4.

## Most influential descendants
- K211931: Medline Digital Thermometer Non-Lubricated Probe Sheath (2021), 0 descendants of its own

## Indications for use
These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Source page: https://510kreport.com/device/K183431
Methodology: https://510kreport.com/methodology