Pacifier Activated Lullaby (PAL®)— 510(k) K151050

Name: FDA 510(k) clearance K151050
Creator: U.S. Food and Drug Administration
Published: 2015-12-22

Substantially Equivalent

Power Medical Devices, LLC

FDA 510(k) clearance K151050 for Pacifier Activated Lullaby (PAL®), Substantially Equivalent on 2015-12-22. Applicant: Power Medical Devices, LLC. Device class: 2.

Clearance details

Applicant: Power Medical Devices, LLC
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2015-04-20
Decision date: 2015-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delray Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K151050

K-number listed on FDA's recall record

Z-0395-2016 — The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.Class II·Ongoing·Powers Medical Devices, LLC·20151001

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151050.

Data sourced from openFDA. This site is unofficial and independent of the FDA.