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
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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.

View all Power Medical Devices, LLC devices

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
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 148d · 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 Peers - HCC Device, Biofeedback

All 23
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K151050.
A Breathing System (ABS)
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Prism
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Freespira
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POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001