Cleared Traditional

SKIL-CARE TURN AND HOLD PAD (K792318) - FDA 510(k) Clearance

Class I General Hospital device.

K792318 · Skil-Care Corp. · General Hospital
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Dec 1979
Decision
31d
Days
Class 1
Risk

K792318 is an FDA 510(k) clearance for the SKIL-CARE TURN AND HOLD PAD. Classified as Device, Transfer, Patient, Manual (product code FMR), Class I - General Controls.

Submitted by Skil-Care Corp. (Walker, US). The FDA issued a Cleared decision on December 20, 1979 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6785 - the FDA general hospital 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 Skil-Care Corp. devices

Submission Details

510(k) Number K792318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date December 20, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMR Device, Transfer, Patient, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6785
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.