# K101244: Skin Sensor Probe, General Purpose Probe, Tympanic Probe

- Pathway: 510(k) (Traditional)
- Applicant: Truer Medical, Inc.
- Decided: Nov 18, 2010 after 198 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient Skin orobe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. T'he skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. OP Probes (OP 9400. OP 9700 and OP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. Tvmvanic Probe (T? 400 and TP' 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K101244
Methodology: https://510kreport.com/methodology