Cleared Traditional

K884122 - TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

K884122 is an FDA 510(k) clearance for TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K884122 · S & W Medico Teknik · Cardiovascular device
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Apr 1989
Decision
207d
Days
Class 2
Risk

K884122 is an FDA 510(k) clearance for the TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on April 25, 1989 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K884122

510(k) Number K884122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date April 25, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 96
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K884122.
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · Baxter Healthcare Corp · Jul 1990
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004 · Advanced Technology Laboratories, Inc. · Mar 1990
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · Baxter Healthcare Corp · Jun 1989
3000 PHYSIOLOGICAL MONITOR
K880301 · Datascope Corp. · Aug 1988
MX1002 CABLE-CAL TM
K880696 · Medex, Inc. · Jun 1988
HORIZON 9000
K875167 · Mennen Medical, Inc. · May 1988