Cleared Traditional

K890935 - SYSTEM 3000 FLUIDIZED AIR BED

K890935 is an FDA 510(k) clearance for SYSTEM 3000 FLUIDIZED AIR BED, manufactured by Dermanetics Corp.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K890935 · Dermanetics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
19d
Days
Class 2
Risk

K890935 is an FDA 510(k) clearance for the SYSTEM 3000 FLUIDIZED AIR BED. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Dermanetics Corp. (Long Beach, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 Dermanetics Corp. devices

FDA 510(k) Submission Details - K890935

510(k) Number K890935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1989
Decision Date March 15, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

All 17
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K890935.
TURBO
K912854 · Kinetic Concepts, Inc. · Dec 1991
CLA-1400 SYSTEM
K914851 · Gaymar Industries, Inc. · Nov 1991
HAZEL
K912855 · Kinetic Concepts, Inc. · Sep 1991
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321 · Kinetic Concepts, Inc. · Jan 1988
ROTATION AIR FLUIDIZED BED/DELTA
K864232 · Kinetic Concepts, Inc. · Dec 1986