Cleared Traditional

K972022 - ZAK-2000

K972022 is an FDA 510(k) clearance for ZAK-2000, manufactured by Cardio Systems, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K972022 · Cardio Systems, Inc. · General Hospital
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Jan 1998
Decision
234d
Days
Class 2
Risk

K972022 is an FDA 510(k) clearance for the ZAK-2000. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Cardio Systems, Inc. (Carrollton, US). The FDA issued a Cleared decision on January 22, 1998 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Systems, Inc. devices

FDA 510(k) Submission Details - K972022

510(k) Number K972022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date January 22, 1998
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 129d · This submission: 234d
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 31
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K972022.
PRESSURE GUARD SITE SELECT (A)
K973169 · Span-America Medical Systems, Inc. · Feb 1998
SIMPULSE
K972549 · Kinetic Concepts, Inc. · Nov 1997
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 1997
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996