Cleared Abbreviated

K162768 - ECG multi leads and IP-SET trunk cable

K162768 is an FDA 510(k) clearance for ECG multi leads and IP-SET trunk cable, manufactured by Integral Process Sas. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Abbreviated 510(k) pathway after a 320-day FDA review.

K162768 · Integral Process Sas · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2017
Decision
320d
Days
Class 2
Risk

K162768 is an FDA 510(k) clearance for the ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and .... Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Integral Process Sas (Conflans Sainte Honorine, FR). The FDA issued a Cleared decision on August 16, 2017 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Integral Process Sas devices

FDA 510(k) Submission Details - K162768

510(k) Number K162768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date August 16, 2017
Days to Decision 320 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
Pathway characteristics
Standards-based clearance path.

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 57
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K162768.
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K172591 · Boston Scientific Corporation · Nov 2017
Unimed Disposable ECG lead wires
K142489 · Unimed Medical Supplies, Inc. · Nov 2014
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · Boston Scientific · Dec 2013
PHILIPS ECG LEADWIRE SET
K110287 · Philips Medical Systems · Feb 2011