Cleared Traditional

K971546 - SOMA 900 TRANSPORT BED

K971546 is an FDA 510(k) clearance for SOMA 900 TRANSPORT BED, manufactured by Nova Technologies, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971546 · Nova Technologies, Inc. · General Hospital
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Jul 1997
Decision
73d
Days
Class 2
Risk

K971546 is an FDA 510(k) clearance for the SOMA 900 TRANSPORT BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Nova Technologies, Inc. (Bristol, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 73 days - a notably fast clearance cycle.

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: 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 Nova Technologies, Inc. devices

FDA 510(k) Submission Details - K971546

510(k) Number K971546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date July 10, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K971546.
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
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VOLKER HOSPITAL BED, MODEL K960
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VAIL 2000 ENCLOSED BED
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VAIL 3000 BED ENCLOSURE
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TOTALCARE
K962942 · Hill-Rom, Inc. · Feb 1997