Cleared Traditional

ELA MEDICAL UNILITH PULSE GENERATOR (K810142) - FDA 510(k) Clearance

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

K810142 · Ela Medical, Inc. · Cardiovascular device
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May 1981
Decision
128d
Days
Class 3
Risk

K810142 is an FDA 510(k) clearance for the ELA MEDICAL UNILITH PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Ela Medical, Inc.. The FDA issued a Cleared decision on May 29, 1981 after a review of 128 days - within the typical 510(k) review window.

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 K810142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date May 29, 1981
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K810142.
MEDTRONIC SPECTRAX
K812153 · Medtronic Vascular · Aug 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · Cordis Corp. · Jul 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · Medtronic Vascular · Jul 1981
MODELS 5976/5977 PACEMAKER PULSE GENER
K810677 · Medtronic, Inc. · May 1981
MEDTRONIC PULSE GENERATOR
K811123 · Medtronic Vascular · May 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221 · Intermedics, Inc. · May 1981