Cleared Traditional

K851731 - ELA MEDICAL PACING LEADS PMC 860 PMCF 8...

K851731 is the FDA 510(k) clearance for ELA MEDICAL PACING LEADS PMC 860 PMCF 8... by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K851731 · Ela Medical, Inc. · Cardiovascular device
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Aug 1985
Decision
126d
Days
Class 3
Risk

K851731 is an FDA 510(k) clearance for the ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 126 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: 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 Ela Medical, Inc. devices

Submission Details

510(k) Number K851731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date August 29, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K851731.
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402
K853222 · Telectronics, Inc. · Sep 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · Telectronics, Inc. · Sep 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · Telectronics, Inc. · Sep 1985
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · Telectronics, Inc. · Jul 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · Telectronics, Inc. · Jul 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · Oscor Medical Corp. · Apr 1985