Cleared Traditional

K911843 - ZERO-G(TM) GEL/FOAM MATTRESS TOPPER

K911843 is an FDA 510(k) clearance for ZERO-G(TM) GEL/FOAM MATTRESS TOPPER, manufactured by Steridyne Corp.. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K911843 · Steridyne Corp. · Physical Medicine device
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May 1991
Decision
35d
Days
Class 1
Risk

K911843 is an FDA 510(k) clearance for the ZERO-G(TM) GEL/FOAM MATTRESS TOPPER. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Steridyne Corp. (Riviera Beach, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3175 - the FDA physical medicine 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 Steridyne Corp. devices

FDA 510(k) Submission Details - K911843

510(k) Number K911843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1991
Decision Date May 30, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

KIC Device Classification - Class 1, General Controls

Product Code KIC Cushion, Flotation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3175
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.

Regulatory Peers - KIC Cushion, Flotation

All 12
Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K911843.
GEL-T CUSHION
K960189 · Span-America Medical Systems, Inc. · Feb 1996
CUSTOMCARE SEATING SYSTEM
K954117 · Span-America Medical Systems, Inc. · Oct 1995
GEL CUSHION
K941858 · Hollister, Inc. · May 1994
PUSH CUSH
K864108 · Medical Industries America, Inc. · Nov 1986
C' AIRECUSH SEAT CUSHION
K864109 · Medical Industries America, Inc. · Nov 1986
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K851027 · Gaymar Industries, Inc. · Jun 1985