Cleared Traditional

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) (K072770) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072770 · Oscor, Inc. · Cardiovascular device
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Jan 2008
Decision
116d
Days
Class 2
Risk

K072770 is an FDA 510(k) clearance for the TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM). Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 22, 2008 after a review of 116 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.

View all Oscor, Inc. devices

Submission Details

510(k) Number K072770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date January 22, 2008
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 51
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K072770.
Temporary Cardiac Pacing Wire
K173923 · Ethicon, Inc. · Aug 2018
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
K152633 · Edwards Lifesciences, LLC · Oct 2015
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
K140972 · Medtronic, Inc. · Jun 2014
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · Medtronic Vascular · Sep 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · Medtronic Vascular · Sep 2004
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc. · Apr 2003