Cleared Traditional

UNILITH PULSE GENERATOR (K791219) - FDA 510(k) Clearance

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

K791219 · Ela Medical, Inc. · Cardiovascular device
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Jul 1979
Decision
27d
Days
Class 3
Risk

K791219 is an FDA 510(k) clearance for the UNILITH PULSE GENERATOR. 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 July 30, 1979 after a review of 27 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 K791219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1979
Decision Date July 30, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
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 K791219.
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · Intermedics, Inc. · Sep 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417 · Intermedics, Inc. · Sep 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · Shiley, Inc. · Aug 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093 · Medtronic Vascular · Jun 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · Cordis Corp. · Feb 1979