Cleared Traditional

K190716 - Streamline 6491 Unipolar Pediatric Temp...

K190716 is the FDA 510(k) clearance for Streamline 6491 Unipolar Pediatric Temp... by Medtronic. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K190716 · Medtronic · Cardiovascular device
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Aug 2019
Decision
142d
Days
Class 2
Risk

K190716 is an FDA 510(k) clearance for the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Uni.... Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic (Santa Ana, US). The FDA issued a Cleared decision on August 8, 2019 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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.

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Submission Details

510(k) Number K190716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2019
Decision Date August 08, 2019
Days to Decision 142 days
Submission Type Traditional
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
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 72
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K190716.
Rotatable Connector (5944RL)
K241199 · Shenzhen Launch Electrical Co., Ltd. · Jan 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
K242705 · Medtronic, Inc. · Jan 2025
TME Temporary Myocardial Electrode
K232261 · Osypka AG · Apr 2024
Temporary Cardiac Pacing Wire
K173923 · Ethicon, Inc. · Aug 2018
Pacel Flow Directed Pacing Catheter
K161873 · St Jude Medical · Nov 2016
Pacel Bipolar Pacing Catheters
K152784 · St Jude Medical · Oct 2015