Cleared Traditional

K972001 - NICAS(TM) ELECTRODE

K972001 is an FDA 510(k) clearance for NICAS(TM) ELECTRODE, manufactured by Ni Medical. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K972001 · Ni Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
39d
Days
Class 2
Risk

K972001 is an FDA 510(k) clearance for the NICAS(TM) ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Ni Medical (Waltham, US). The FDA issued a Cleared decision on July 8, 1997 after a review of 39 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.

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FDA 510(k) Submission Details - K972001

510(k) Number K972001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date July 08, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
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 153
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K972001.
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · 3M Healthcare · Jul 1998
PALJET-B
K973663 · Golden Gate Bio-Device · Feb 1998
ELECTRODE, ELECTROCARDIOGRAPH
K973727 · Don Tay Industries · Dec 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · 3M Medical Products Group · Jun 1997
STEALTHSHIELD
K970755 · Vital Connections, Inc. · Apr 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · 3M Healthcare · Apr 1997