Cleared Traditional

K827296 - POLYSONIC ULTRASOUND LOTION

K827296 is an FDA 510(k) clearance for POLYSONIC ULTRASOUND LOTION, manufactured by Parker Laboratories, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K827296 · Parker Laboratories, Inc. · Radiology device
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Apr 1982
Decision
17d
Days
Class 2
Risk

K827296 is an FDA 510(k) clearance for the POLYSONIC ULTRASOUND LOTION. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on April 16, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Parker Laboratories, Inc. devices

FDA 510(k) Submission Details - K827296

510(k) Number K827296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date April 16, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUI Device Classification - Class 2, Special Controls

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.