# K061942: Tympanic Temperature Probe with Foam, Model M1024233; Without Foam Model M1024237

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 29, 2006 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: 1 generation back to K925792 (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)
- K925792: Exac-Temp & Clini-Temp Tympanic & Myocardial Probe, Deroyal Industries, Inc. (1994) Summary page 1.

## Indications for use
The Tympanic Temperature Probe is intended for atraumatic placement in proximity of the tympanic membrane. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to the temperature probe usage. The device is indicated for use by qualified medical personnel only

Source page: https://510kreport.com/device/K061942
Methodology: https://510kreport.com/methodology