Cleared Traditional

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS (K963620) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963620 · 9th Wave, Inc. · General Hospital
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Jan 1997
Decision
119d
Days
Class 2
Risk

K963620 is an FDA 510(k) clearance for the 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by 9th Wave, Inc. (Mt Pleasant, US). The FDA issued a Cleared decision on January 7, 1997 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - 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 9th Wave, Inc. devices

Submission Details

510(k) Number K963620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date January 07, 1997
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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.