# K120815: Innersense Esophageal Temperature/Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Mar 6, 2013 after 352 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K131590: Innersense Esophageal Temperature Probe / Feeding Tube (2013), 1 descendant of its own
- K241169: Entarik NI Feeding Tube System (2024), 0 descendants of its own

## Indications for use
The InnerSense Esophageal Temperature/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician far up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.

Source page: https://510kreport.com/device/K120815
Methodology: https://510kreport.com/methodology