# K070339: Disposable Temperature Probes/Sensors and Instrument Cables

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Sep 26, 2007 after 233 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith's Level I Temperature Probes and Cables (Skin Temperature Sensor STS400; Tympanic Temperature Sensors TT400, TTSP-400, TTS-400J; Cables C400-10 and C400-IOHP): named in the summary without a submission number

## Most influential descendants
- K152973: Dyna-Vision Telemonitoring System (2016), 0 descendants of its own

## Indications for use
Skin Temperature Sensor (487M and 499B): The CSZ skin temperature sensor is intended for use in routine continuous monitoring skin temperature when the other sensors which might better reflect core body temperature are not indicated clinically. The sensor is designed for placement on the surface of the skin. Tympanic Temperature Sensor (495M and 495M-P): The tympanic temperature sensor is intended for use in routine continuous monitoring tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated. Instrument Cables (4872MS and 4900B): The intended use of the instrument cable is to interconnect the disposable temperature sensor/probe with the temperature monitoring instrument.

Source page: https://510kreport.com/device/K070339
Methodology: https://510kreport.com/methodology