Cleared Traditional

K952659 - TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM

K952659 is the FDA 510(k) clearance for TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM by Tronomed, Inc.. It is a Class 2 Cardiovascular device (product code DSA) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K952659 · Tronomed, Inc. · Cardiovascular device
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Jan 1996
Decision
213d
Days
Class 2
Risk

K952659 is an FDA 510(k) clearance for the TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Tronomed, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Tronomed, Inc. devices

Submission Details

510(k) Number K952659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date January 11, 1996
Days to Decision 213 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K952659.
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
K013598 · C.R. Bard, Inc. · Jan 2002
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · Biosense Webster, Inc. · Jul 2000
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
K945034 · Conmedcorp · Oct 1994
CONMED ECG PATIENT CABLES AND LEADWIRES
K933649 · Conmedcorp · Feb 1994
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
K901780 · Medtronic Vascular · Oct 1990