Cleared Traditional

K952659 - TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM

K952659 is an FDA 510(k) clearance for TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM, manufactured by Tronomed, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K952659

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
Combination Product No
PCCP Authorized No
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.

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 71
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K952659.
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
K971968 · Remington Medical, Inc. · Jul 1997
3M RED DOT ECG LEAD WIRES A
K954900 · Minnesota Mining and Mfg. Co. · Jul 1996
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
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · Remington Medical, Inc. · Feb 1993