# K010388: Sondrex P.a.L. System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Dec 11, 2001 after 306 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071866: Ntrainer System (2008), 1 descendant of its own
- K151050: Pacifier Activated Lullaby (PAL®) (2015), 0 descendants of its own
- K143507: NFANT Feeding Solution (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K010388
Methodology: https://510kreport.com/methodology