# K112547: Neo Nest

- Pathway: 510(k) (Traditional)
- Applicant: Denovo Proucts, LLC
- Decided: Mar 6, 2012 after 187 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K163295: Infant Transport Mattress Warmer with Disc (2017), 1 descendant of its own
- K221653: InfaTherm Disposable Infant Warming Mattress (2022), 0 descendants of its own

## Indications for use
Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.

Source page: https://510kreport.com/device/K112547
Methodology: https://510kreport.com/methodology