# K083419: Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020

- Pathway: 510(k) (Traditional)
- Applicant: Actherm, Inc.
- Decided: Jul 16, 2009 after 239 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: 3 generations back to K871465 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K063418: Acon Digital Thermometer Probe Covers, ACON Laboratories, Inc. (2007) Summary page 1.

## Indications for use
The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use: when temperature taking.

Source page: https://510kreport.com/device/K083419
Methodology: https://510kreport.com/methodology