Cleared Traditional

K832845 - EGERTON TURNING & TILTING NET SUSPEN BED (FDA 510(k) Clearance)

Class I General Hospital device.

K832845 · Kinetic Concepts, Inc. · General Hospital
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Nov 1983
Decision
98d
Days
Class 1
Risk

K832845 is an FDA 510(k) clearance for the EGERTON TURNING & TILTING NET SUSPEN BED. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Kinetic Concepts, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kinetic Concepts, Inc. devices

Submission Details

510(k) Number K832845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date November 28, 1983
Days to Decision 98 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
30d faster than avg
Panel avg: 128d · This submission: 98d
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.