Cleared Traditional

K953649 - DISPOSABLE ECG ELECTRODE

K953649 is an FDA 510(k) clearance for DISPOSABLE ECG ELECTRODE, manufactured by Kendall-Ltp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K953649 · Kendall-Ltp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
322d
Days
Class 2
Risk

K953649 is an FDA 510(k) clearance for the DISPOSABLE ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Kendall-Ltp (Chicopee, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Kendall-Ltp devices

FDA 510(k) Submission Details - K953649

510(k) Number K953649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date June 21, 1996
Days to Decision 322 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
197d slower than avg
Panel avg: 125d · This submission: 322d
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 179
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K953649.
PACEART WRIST ELECTRODES
K960721 · Paceart, Inc. · Jul 1996
QUICKELS QS 200 SYSTEM
K954772 · Ferguson Medical · Jul 1996
QUICKELS QS 100 SYSTEM
K954773 · Ferguson Medical · Jul 1996
MEDI-TRACE RADIOLUCENT
K961395 · Graphic Controls Corp. · Jun 1996
UNILECT, MONITAB AND BIOTRACE-HR
K944497 · Msb , Ltd. · May 1996
SI2000 (SENSE-IT TRADEMARK) OR G2000
K955800 · Cmc Sense-It, Inc. · May 1996