Cleared Traditional

K884122 - TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

K884122 is the FDA 510(k) clearance for TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA by S & W Medico Teknik. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

Device Classification

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 48
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K884122.
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414 · Abbott Laboratories · Nov 1994
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · Baxter Healthcare Corp · Jul 1990
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · Baxter Healthcare Corp · Jun 1989
3000 PHYSIOLOGICAL MONITOR
K880301 · Datascope Corp. · Aug 1988
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · American Edwards Laboratories · Sep 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987