Cleared Traditional

K884117 - TYPE 9210 ECG SYSTEM ATHENA

K884117 is the FDA 510(k) clearance for TYPE 9210 ECG SYSTEM ATHENA by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K884117 · S & W Medico Teknik · Cardiovascular device
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Apr 1989
Decision
208d
Days
Class 2
Risk

K884117 is an FDA 510(k) clearance for the TYPE 9210 ECG SYSTEM ATHENA. 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 April 26, 1989 after a review of 208 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

Submission Details

510(k) Number K884117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date April 26, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K884117.
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