Cleared Traditional

K102430 - TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET

K102430 is an FDA 510(k) clearance for TYCO ELECTRONICS ELECTROCARDIOGRAPH (EC..., manufactured by Tyco Electronics Corporation. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K102430 · Tyco Electronics Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
15d
Days
Class 2
Risk

K102430 is an FDA 510(k) clearance for the TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Tyco Electronics Corporation (Wilsonville, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Tyco Electronics Corporation devices

FDA 510(k) Submission Details - K102430

510(k) Number K102430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date September 10, 2010
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 58
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