Cleared Traditional

K963701 - SOMA SAFE ENCLOSURE

K963701 is the FDA 510(k) clearance for SOMA SAFE ENCLOSURE by Nova Technology Corp.. It is a Class 2 General Hospital device (product code FNL) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K963701 · Nova Technology Corp. · General Hospital
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Jan 1997
Decision
130d
Days
Class 2
Risk

K963701 is an FDA 510(k) clearance for the SOMA SAFE ENCLOSURE. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Nova Technology Corp. (Bristol, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Nova Technology Corp. devices

Submission Details

510(k) Number K963701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date January 24, 1997
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FNL Bed, Ac-powered Adjustable Hospital

All 16
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K963701.
IBED WIRELESS WITH IBED AWARENESS
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GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993