Cleared Traditional

SKIL-CARE BED RAIL PADS (K791993) - FDA 510(k) Clearance

Class I General Hospital device.

K791993 · Skil-Care Corp. · General Hospital
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Oct 1979
Decision
23d
Days
Class 1
Risk

K791993 is an FDA 510(k) clearance for the SKIL-CARE BED RAIL PADS. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Skil-Care Corp. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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 K791993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1979
Decision Date October 26, 1979
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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.