# DEN240031: Prapela SVS hospital bassinet pad (model P01)

- Pathway: De Novo (Direct)
- Applicant: Prapela, Inc.
- Decided: Apr 4, 2025 after 291 days
- Product code: QVY (Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome)
- Device class: 2
- Regulation: 21 CFR 880.5151
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Prapela SVS hospital bassinet pad is indicated as adjunctive non-pharmacological therapy in newborns ≥37 weeks gestational age exposed prenatally to opioids with neonatal opioid withdrawal syndrome (NOWS). The Prapela SVS hospital bassinet pad is indicated for prescription use only.

Source page: https://510kreport.com/device/DEN240031
Methodology: https://510kreport.com/methodology