Cleared Traditional

K151050 - Pacifier Activated Lullaby (PAL®)

K151050 is an FDA 510(k) clearance for Pacifier Activated Lullaby (PAL), manufactured by Power Medical Devices, LLC. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K151050 · Power Medical Devices, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
246d
Days
Class 2
Risk

K151050 is an FDA 510(k) clearance for the Pacifier Activated Lullaby (PAL®). Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Power Medical Devices, LLC (Delray Beach, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 246 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151050

510(k) Number K151050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date December 22, 2015
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 149d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Consultant

MEDIcept, Inc.
Sharyn Orton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HCC Device, Biofeedback

All 102
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K151050 · Pacifier Activated Lullaby (PAL®)
Download PDF FDA Summary Power Medical Devices…