Cleared Traditional

K830401 - UNILITH PULSE GENERATOR VVI #7542

K830401 is the FDA 510(k) clearance for UNILITH PULSE GENERATOR VVI #7542 by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

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
Combination Product No
PCCP Authorized No
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K830401.
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · Pacesetter Systems · Mar 1983
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K830390 · Telectronics, Inc. · Mar 1983
COMMAND ULTRA II
K830382 · Cardiac Pacemakers, Inc. · Mar 1983
MEDTRONIC MODELS 59401 5941
K823831 · Medtronic Vascular · Mar 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · Intermedics, Inc. · Mar 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · Pacesetter Systems · Feb 1983