# K970334: Nature's Cradle

- Pathway: 510(k) (Traditional)
- Applicant: Infant Advantage, Inc.
- Decided: Apr 25, 1997 after 87 days
- Product code: FMS (Bed, Pediatric Open Hospital)
- Device class: 2
- Regulation: 21 CFR 880.5140
- 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 K901763 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960747: Nature's Cradle Model C1500, Infant Advantage, Inc. (1996) Summary page 1.
- K901763: Nature's Cradle (TM), Infant Advantage, Inc. (1991) Summary page 1.

## Indications for use
Nature’s Cradle® C2000 Series is indicated for healthy, full term infants at home or hospital.

Source page: https://510kreport.com/device/K970334
Methodology: https://510kreport.com/methodology