Cleared Special

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K031210 · Metronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
29d
Days
Class 3
Risk

K031210 is an FDA 510(k) clearance for the MODEL 4951M MYOCARDIAL UNIPOLAR LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 16, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Metronic, Inc. devices

Submission Details

510(k) Number K031210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date May 16, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 486
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K031210.
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
MODEL 430-07 ENDOCARDIAL PACING LEAD
K954610 · Intermedics, Inc. · Dec 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K955122 · Intermedics, Inc. · Nov 1996
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
K962036 · Medtronic Vascular · Aug 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174 · Intermedics, Inc. · Aug 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · Medtronic Vascular · Aug 1996