Cleared Traditional

PIRD-Y (K842262) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842262 · Pirdy, Inc. · Physical Medicine device
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Jun 1984
Decision
21d
Days
Class 2
Risk

K842262 is an FDA 510(k) clearance for the PIRD-Y. Classified as Stimulator, Muscle, Diagnostic (product code ISB), Class II - Special Controls.

Submitted by Pirdy, Inc. (Walker, US). The FDA issued a Cleared decision on June 28, 1984 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1850 - the FDA physical medicine 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: 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 Pirdy, Inc. devices

Submission Details

510(k) Number K842262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date June 28, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISB Stimulator, Muscle, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1850
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 Physical Medicine devices follow this clearance model.