Cleared Special

K172591 - Fixed Patient Leads ECG Cable (Model 3153)

K172591 is an FDA 510(k) clearance for Fixed Patient Leads ECG Cable (Model 3153), manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Special 510(k) pathway after a 66-day FDA review.

K172591 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
66d
Days
Class 2
Risk

K172591 is an FDA 510(k) clearance for the Fixed Patient Leads ECG Cable (Model 3153). Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on November 3, 2017 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172591

510(k) Number K172591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2017
Decision Date November 03, 2017
Days to Decision 66 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 105
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K172591.
Curbell branded Patient Monitoring Cables
K182220 · Curbell Medical Products, Inc. · Nov 2018
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018
ECG Cable/Leadwires
K172797 · Shenzhen Coreray Technology, Ltd. · Feb 2018
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 · Integral Process Sas · Aug 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
K172591 · Fixed Patient Leads ECG Cable (Model 3153)
Download PDF FDA Summary Boston Scientific Cor…