Cleared Traditional

K894920 - SELECTRODE

K894920 is an FDA 510(k) clearance for SELECTRODE, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K894920 · S & W Medico Teknik · Cardiovascular device
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Oct 1989
Decision
62d
Days
Class 2
Risk

K894920 is an FDA 510(k) clearance for the SELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on October 3, 1989 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K894920

510(k) Number K894920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date October 03, 1989
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 147
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K894920.
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · Marquette Electronics, Inc. · Nov 1989
ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
K894991 · Labeltape Meditect, Inc. · Oct 1989
CARE DISP. DIAG. ELECTRODES, SILVER/SILVER
K894462 · Labeltape Meditect, Inc. · Oct 1989
VITATRACE
K893425 · Lectec Corp. · Jul 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · S & W Medico Teknik · May 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989