Cleared Traditional

K912049 - SYSTEM ATHENA - PRODUCT ENHANCEMENTS

K912049 is an FDA 510(k) clearance for SYSTEM ATHENA - PRODUCT ENHANCEMENTS, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K912049 · S & W Medico Teknik · Cardiovascular device
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Dec 1991
Decision
240d
Days
Class 2
Risk

K912049 is an FDA 510(k) clearance for the SYSTEM ATHENA - PRODUCT ENHANCEMENTS. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on December 5, 1991 after a review of 240 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 - K912049

510(k) Number K912049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date December 05, 1991
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 201
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K912049.
SYSTEM ATHENA, MODIFICATION
K911611 · S & W Medico Teknik · Feb 1993
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · Hewlett-Packard Co. · Nov 1992
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665 · Ge Medical Systems Information Technologies · Dec 1991
DATASCOPE PASSPORT MONITOR
K911598 · Datascope Corp. · Oct 1991
EDENTEC MODEL 3711 DIGITAL RECORDER
K910870 · Edentec Corp. · Aug 1991
507 NON-INVASIVE VITAL SIGNS MONITOR
K910852 · Criticare Systems, Inc. · Jul 1991