Cleared Abbreviated

K162768 - ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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 91
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K162768.
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation · Nov 2017
Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
K163316 · Carefusion 303, Inc. · Jun 2017
ECG Disposable Lead Wire
K170536 · APK Technology Co., Ltd. · Apr 2017
Multi-Link X2 ECG Cable and Lead Wire System
K162432 · Carefusion 2200, Inc. · Jan 2017