# DEN150053: Fetal Pillow

- Pathway: De Novo (Direct)
- Applicant: Safe Obstetric Systems, Ltd.
- Decided: Jul 27, 2017 after 617 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243799: Fetal Pillow (2025), 0 descendants of its own

## 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/DEN150053
Methodology: https://510kreport.com/methodology