Cleared Traditional

K912183 - TYPE 9050/NEO

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

K912183 · S & W Medico Teknik · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K912183

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 326
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K912183.
KING OF HEARTS SCEPTER
K923221 · Instromedix, Inc. · Mar 1993
MORTARA INSTRUMENT ST CENTRAL STATION
K922927 · Mortara Instrument, Inc. · Nov 1992
PERSONAL 120/210 LAPTOP STRESS OPTION
K922291 · Biosound, Inc. · Nov 1992
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · Biosound, Inc. · Mar 1992
HL-300 RECEIVER MODULE
K915879 · Fukuda Denshi USA, Inc. · Jan 1992
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991