Not Cleared Direct

DEN240031 - Prapela SVS hospital bassinet pad (model P01) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240031 · Prapela, Inc. · General Hospital
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Apr 2025
Decision
291d
Days
Class 2
Risk

DEN240031 is an FDA 510(k) submission (not cleared) for the Prapela SVS hospital bassinet pad (model P01). Classified as Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome (product code QVY), Class II - Special Controls.

Submitted by Prapela, Inc. (Biddeford, US). The FDA issued a Not Cleared (DENG) decision on April 4, 2025 after a review of 291 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5151 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 291 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Prapela, Inc. devices

Submission Details

510(k) Number DEN240031 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 17, 2024
Decision Date April 04, 2025
Days to Decision 291 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 128d · This submission: 291d
Pathway characteristics

Device Classification

Product Code QVY Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5151
Definition Reusable Hospital Mattress Pad With Integrated Mechanical Vibrations To Be Used As Adjunctive Therapy For Neonates And Infants With Neonatal Abstinence Syndrome (nas) Or Neonatal Opioid Withdrawal Syndrome (nows).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.