Cleared Traditional

K884118 - TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

K884118 is the FDA 510(k) clearance for TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA by S & W Medico Teknik. It is a Class 2 Cardiovascular device (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

Submission Details

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
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 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 9
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K884118.
Endophys Blood Pressure Monitor model BPM-30
K231586 · Endophys Technologies, LLC · Nov 2023
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · Welch Allyn, Inc. · May 1993
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979