# K111282: Disposable Temperature Probes / Sensors and Interconnect Instrument Cables

- Pathway: 510(k) (Traditional)
- Applicant: Starboard Medical, LLC
- Decided: Aug 11, 2011 after 97 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 K864195 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864195: Surface Skin Temp Probe W/Thermocouple Type T, Respiratory Support Products, Inc. (1986) Summary page 1.
- K873205: Tympanic Temperature Sensor, Respiratory Support Products, Inc. (1988) Summary page 1.

## Indications for use
The Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin. The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane. The instwument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.

Source page: https://510kreport.com/device/K111282
Methodology: https://510kreport.com/methodology