# K071866: Ntrainer System

- Pathway: 510(k) (Traditional)
- Applicant: Kcbiomedix, Inc.
- Decided: Feb 1, 2008 after 210 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K951213 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010388: Sondrex P.a.L. System, Ohmeda Medical (2001) Summary page 1.
- K980373: Ultramind Biofeedback System with DE-Stress Software, Ultramind International, Ltd. (1998) Summary page 1.

## Most influential descendants
- K143507: NFANT Feeding Solution (2015), 0 descendants of its own

## Indications for use
The NTrainer System reinforces non-nutritive suck (NNS) in newborns and infants born prematurely.

Source page: https://510kreport.com/device/K071866
Methodology: https://510kreport.com/methodology