Cleared Traditional

K000690 - 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

K000690 is an FDA 510(k) clearance for 3M RED DOT RADIOLUCENT MONITORING ELECT..., manufactured by Minnesota Mining and Mfg. Co.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K000690 · Minnesota Mining and Mfg. Co. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
78d
Days
Class 2
Risk

K000690 is an FDA 510(k) clearance for the 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Minnesota Mining and Mfg. Co. (St. Paul, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 78 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.

FDA 510(k) Submission Details - K000690

510(k) Number K000690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date May 17, 2000
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 252
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K000690.
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
K003804 · Niko Medical Products · Aug 2001
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000
V QUICK PATCH
K993934 · Vq Corp. · Aug 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
K000206 · Axelgaard Mfg. Co., Ltd. · Apr 2000
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · Maersk Medical A/S · Dec 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · Maersk Medical A/S · Dec 1999
K000690 · 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
Download PDF FDA Summary Minnesota Mining and …