Cleared Traditional

K982521 - SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES

K982521 is an FDA 510(k) clearance for SKINTACT ECG ELECTRODES, manufactured by Leonhard Lang Co.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K982521 · Leonhard Lang Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
463d
Days
Class 2
Risk

K982521 is an FDA 510(k) clearance for the SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Leonhard Lang Co. (Innsbruck, AT). The FDA issued a Cleared decision on October 26, 1999 after a review of 463 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: 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 Leonhard Lang Co. devices

FDA 510(k) Submission Details - K982521

510(k) Number K982521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date October 26, 1999
Days to Decision 463 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 125d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Product Service, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 156
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K982521.
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
K983689 · Medicotest A/S · Jan 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
ECG ELECTRODES APRON
K982470 · Tapuz Medical Technology , Ltd. · Oct 1998