# K060173: Acon 30 Second Reliable Digital Thermometer, Acon Digital Thermometer Probe Covers

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Mar 17, 2006 after 53 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 K935267 (1994). 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)
- K935267: B-D Digital Thermometer, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Indications for use
The ACON 30 Second Reliable Digital Thermometer and the ACONTM Digital Thermometer Probe Covers are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm, and/or rectally. It is intended to be sold over-the-counter for home use by lay persons without any professional training.

Source page: https://510kreport.com/device/K060173
Methodology: https://510kreport.com/methodology