Cleared Traditional

K790320 - DELTA-LITE (FDA 510(k) Clearance)

Class I Physical Medicine device.

K790320 · Johnson & Johnson Professionals, Inc. · Physical Medicine device
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May 1979
Decision
92d
Days
Class 1
Risk

K790320 is an FDA 510(k) clearance for the DELTA-LITE. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on May 18, 1979 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K790320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1979
Decision Date May 18, 1979
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITG Bandage, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.