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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Sud America, Inc.
DAWN TIBODEAU

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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 94
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K102430 · TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
Download PDF FDA Summary Tyco Electronics Corp…