Cleared Traditional

MEDICAL MULTILITH PULSE GENERA-1140 (K813246) - FDA 510(k) Clearance

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

K813246 · Ela Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
86d
Days
Class 3
Risk

K813246 is an FDA 510(k) clearance for the MEDICAL MULTILITH PULSE GENERA-1140. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 K813246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1981
Decision Date February 12, 1982
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K813246.
MEDTRONIC ENERTRAX MODEL 7100
K822147 · Medtronic Vascular · Aug 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · Intermedics, Inc. · Apr 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356 · Cordis Corp. · Mar 1982
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · Intermedics, Inc. · Sep 1981
TELEMETRY DECODER
K801339 · Intermedics, Inc. · Sep 1981
MEDTRONIC MODEL 2409
K812580 · Medtronic Vascular · Sep 1981