Cleared Traditional

K080112 - PATIENT CABLE

K080112 is an FDA 510(k) clearance for PATIENT CABLE, manufactured by Med-Dyne. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K080112 · Med-Dyne · Cardiovascular device
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Jun 2008
Decision
156d
Days
Class 2
Risk

K080112 is an FDA 510(k) clearance for the PATIENT CABLE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Med-Dyne (Louisville, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 156 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 Med-Dyne devices

FDA 510(k) Submission Details - K080112

510(k) Number K080112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2008
Decision Date June 20, 2008
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
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 63
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K080112.
ADAGIO RETRACTING ECG LEAD WIRES
K093657 · Acist Medical Systems, Inc. · Jan 2010
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · Ge Medical Systems Information Technologies · Nov 2008
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · Unimed Medical Supplies, Inc. · Oct 2008
COMPATIBILITY ECG TRUNK CABLES
K043572 · Datex-Ohmeda · Feb 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
K030005 · Vanguard Medical Concepts, Inc. · Mar 2003
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
K023334 · Baylis Medical Co., Inc. · Dec 2002