# K110956: Medivance Nasogastric Tube Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Medivance, Inc.
- Decided: Jul 18, 2011 after 104 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: 2 generations back to K864044 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935603: Extracorporeal Temperature Sensor, Smiths Industries Medical Systems, Inc. (1994) Summary page 1.
- K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor, Cincinnati Sub-Zero Products, Inc. (2007) Summary page 1.
- (no number) Steri-Temp Esophageal Temperature Probe: named in the summary without a submission number

## Indications for use
The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FIR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.

Source page: https://510kreport.com/device/K110956
Methodology: https://510kreport.com/methodology