Cleared Traditional

K160260 - Tempo Temporary Pacing Lead

K160260 is an FDA 510(k) clearance for Tempo Temporary Pacing Lead, manufactured by Biotrace Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K160260 · Biotrace Medical, Inc. · Cardiovascular device
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Oct 2016
Decision
267d
Days
Class 2
Risk

K160260 is an FDA 510(k) clearance for the Tempo Temporary Pacing Lead. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Biotrace Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 25, 2016 after a review of 267 days - an extended review cycle.

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.

View all Biotrace Medical, Inc. devices

FDA 510(k) Submission Details - K160260

510(k) Number K160260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date October 25, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K160260.
Temporary Cardiac Pacing Wire
K173923 · Ethicon, Inc. · Aug 2018
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
K171253 · Medtronic · May 2017
Pacel Flow Directed Pacing Catheter
K161873 · St Jude Medical · Nov 2016
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · Medtronic · Aug 2016
Pacel Bipolar Pacing Catheters
K152784 · St Jude Medical · Oct 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
K152633 · Edwards Lifesciences, LLC · Oct 2015