Cleared Traditional

K912183 - TYPE 9050/NEO

K912183 is the FDA 510(k) clearance for TYPE 9050/NEO by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K912183 · S & W Medico Teknik · Cardiovascular device
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Jun 1992
Decision
404d
Days
Class 2
Risk

K912183 is an FDA 510(k) clearance for the TYPE 9050/NEO. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on June 23, 1992 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all S & W Medico Teknik devices

Submission Details

510(k) Number K912183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date June 23, 1992
Days to Decision 404 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 125d · This submission: 404d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 162
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K912183.
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
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K941811 · Hewlett-Packard Co. · May 1994
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990