# K063418: Acon Digital Thermometer Probe Covers

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Feb 2, 2007 after 81 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 1.

## Most influential descendants
- K083419: Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 (2009), 0 descendants of its own

## Indications for use
The ACON TM Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.

Source page: https://510kreport.com/device/K063418
Methodology: https://510kreport.com/methodology