Cleared Traditional

K962123 - AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM

K962123 is an FDA 510(k) clearance for AKROTECH 4000T KINETIC TURNING LOW AIR ..., manufactured by Lumex, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K962123 · Lumex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
48d
Days
Class 2
Risk

K962123 is an FDA 510(k) clearance for the AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Lumex, Inc. (Bay Shore, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 48 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 Lumex, Inc. devices

FDA 510(k) Submission Details - K962123

510(k) Number K962123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date July 18, 1996
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
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 51
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K962123.
AIR-MEDEX I
K961769 · Robert Gold Assoc. · Oct 1996
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · Span-America Medical Systems, Inc. · Jun 1996
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960620 · Span-America Medical Systems, Inc. · Apr 1996
AREMA II
K961129 · Mellen Air Mfg., Inc. · Apr 1996