Cleared Traditional

ECONO-FLOAT WATER FLOTATION MATTRESS (K780779) - FDA 510(k) Clearance

Class I General Hospital device.

K780779 · Jefferson Industries, Inc. · General Hospital
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May 1978
Decision
8d
Days
Class 1
Risk

K780779 is an FDA 510(k) clearance for the ECONO-FLOAT WATER FLOTATION MATTRESS. Classified as Mattress, Flotation Therapy, Non-powered (product code IKY), Class I - General Controls.

Submitted by Jefferson Industries, Inc. (Walker, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5150 - 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 Jefferson Industries, Inc. devices

Submission Details

510(k) Number K780779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1978
Decision Date May 19, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKY Mattress, Flotation Therapy, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5150
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.