Cleared Traditional

K884118 - TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

K884118 is an FDA 510(k) clearance for TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K884118 · S & W Medico Teknik · Cardiovascular device
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Apr 1989
Decision
207d
Days
Class 2
Risk

K884118 is an FDA 510(k) clearance for the TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA. Classified as Computer, Blood-pressure (product code DSK), 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 870.1110 - 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 - K884118

510(k) Number K884118 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.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 48
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K884118.
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514 · Ppg Industries, Inc. · Nov 1990
MEDILOG OPTIMA
K896535 · Oxford Medilog, Inc. · Jan 1990
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
K893232 · Camino Laboratories, Inc. · Jul 1989
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · Datex Division Instrumentarium Corp. · Jul 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · A&D Engineering, Inc. · Mar 1988
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610
K874338 · A&D Engineering, Inc. · Feb 1988