Cleared Traditional

K832845 - EGERTON TURNING & TILTING NET SUSPEN BED

K832845 is an FDA 510(k) clearance for EGERTON TURNING & TILTING NET SUSPEN BED, manufactured by Kinetic Concepts, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K832845

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

FNJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - FNJ Bed, Manual

All 7
Devices cleared under the same product code (FNJ) and FDA review panel - the closest regulatory comparables to K832845.
CRADLE, HOSPITAL BED CLOTHING
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SIDE RAIL PADS
K823821 · Danek Medical, Inc. · Jan 1983
TELESCOPING BEDRAILS
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TRAPEZE FLOOR BASE
K772261 · Med Fusion Systems, Inc. · Jan 1978
TRAPEZE BAR KNOCKED DOWN
K772262 · Med Fusion Systems, Inc. · Jan 1978