Cleared Traditional

LEAD MODELS MUM 1260, MUM 1290 (K790386) - FDA 510(k) Clearance

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

K790386 · Ela Medical, Inc. · Cardiovascular device
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Apr 1979
Decision
36d
Days
Class 3
Risk

K790386 is an FDA 510(k) clearance for the LEAD MODELS MUM 1260, MUM 1290. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 36 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. 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 K790386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date April 03, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K790386.
MEDTRONIC MODELS 6907/6901
K790766 · Medtronic Vascular · May 1979
BIPOLAR PERNENOUS VENTRICULAR LEAD
K790344 · Cordis Corp. · Apr 1979
MEDTRONIC MODEL 6972
K790462 · Medtronic Vascular · Apr 1979
MEDTRONIC MODEL 6971
K790074 · Medtronic Vascular · Mar 1979
MEDTRONIC TEMPTRON
K790261 · Medtronic Vascular · Feb 1979
LIFELINE PACING LEAD MODEL 465-01
K781497 · Intermedics, Inc. · Feb 1979