Cleared Traditional

K941858 - GEL CUSHION

K941858 is an FDA 510(k) clearance for GEL CUSHION, manufactured by Hollister, Inc.. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K941858 · Hollister, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
20d
Days
Class 1
Risk

K941858 is an FDA 510(k) clearance for the GEL CUSHION. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on May 5, 1994 after a review of 20 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K941858

510(k) Number K941858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1994
Decision Date May 05, 1994
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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

Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K941858.
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K851027 · Gaymar Industries, Inc. · Jun 1985
PRESSURE RELIEF SEAT CUSHION
K842380 · American Pharmaseal Div. Ahsc · Jun 1984
INFLATABLE INVALID RING
K830426 · Maddak, Inc. · Apr 1983
ARM CUSHION
K830427 · Maddak, Inc. · Mar 1983
SILICONE ELBOW, BED AND CHAIR PADS
K810440 · Fred Sammons, Inc. · Mar 1981
CONPHAR INVALID RING
K803137 · Conphar, Inc. · Jan 1981