Cleared Traditional

UNILITH PULSE GENERATOR VVI #7542 (K830401) - FDA 510(k) Clearance

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

K830401 · Ela Medical, Inc. · Cardiovascular device
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Mar 1983
Decision
38d
Days
Class 3
Risk

K830401 is an FDA 510(k) clearance for the UNILITH PULSE GENERATOR VVI #7542. 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 March 17, 1983 after a review of 38 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 K830401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date March 17, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K830401.
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199 · Intermedics, Inc. · Oct 1983
SILICONE RUBBER ISOLATION SLEEVE 351-01
K833198 · Intermedics, Inc. · Oct 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · Intermedics, Inc. · Oct 1983
MEDTRONIC MODELS 59401 5941
K823831 · Medtronic Vascular · Mar 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · Intermedics, Inc. · Mar 1983
TELEMETRY DECODER #540-02
K823678 · Intermedics, Inc. · Dec 1982