Cleared Traditional

K890012 - HUNTLEIGH DYNAMIC FLOTATION SYSTEM

K890012 is an FDA 510(k) clearance for HUNTLEIGH DYNAMIC FLOTATION SYSTEM, manufactured by Huntleigh Technology, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K890012 · Huntleigh Technology, Inc. · General Hospital
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Mar 1989
Decision
85d
Days
Class 2
Risk

K890012 is an FDA 510(k) clearance for the HUNTLEIGH DYNAMIC FLOTATION SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Huntleigh Technology, Inc. (Manalapan, US). The FDA issued a Cleared decision on March 29, 1989 after a review of 85 days - a notably fast clearance cycle.

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: 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 Huntleigh Technology, Inc. devices

FDA 510(k) Submission Details - K890012

510(k) Number K890012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1989
Decision Date March 29, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 19
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K890012.
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901 · Kinetic Concepts, Inc. · Oct 1990
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K882644 · Huntleigh Technology, Inc. · Aug 1988
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
K882092 · Gaymar Industries, Inc. · Jul 1988
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872228 · American Pharmaseal Div. Ahsc · Sep 1987