Cleared Traditional

K780422 - PINWHEEL (FDA 510(k) Clearance)

Class I Neurology device.

K780422 · Projects IN Health · Neurology device
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Apr 1978
Decision
18d
Days
Class 1
Risk

K780422 is an FDA 510(k) clearance for the PINWHEEL. Classified as Pinwheel (product code GWY), Class I - General Controls.

Submitted by Projects IN Health (Mchenry, US). The FDA issued a Cleared decision on April 4, 1978 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K780422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1978
Decision Date April 04, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWY Pinwheel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.