Cleared Traditional

KING KRIB (K934298) - FDA 510(k) Clearance

Class I General Hospital device.

K934298 · Noritage, Inc. · General Hospital
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Jan 1994
Decision
146d
Days
Class 1
Risk

K934298 is an FDA 510(k) clearance for the KING KRIB. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Noritage, Inc. (Great Neck,, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 146 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 Noritage, Inc. devices

Submission Details

510(k) Number K934298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1993
Decision Date January 26, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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.