# K243799: Fetal Pillow

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Aug 29, 2025 after 261 days
- Product code: PWB (Fetal Head Elevator)
- Device class: 2
- Regulation: 21 CFR 884.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150053 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150053: Fetal Pillow, Safe Obstetric Systems, Ltd. (2017) Summary page 5.

## Indications for use
Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

Source page: https://510kreport.com/device/K243799
Methodology: https://510kreport.com/methodology