Cleared Traditional

OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 (K882391) - FDA 510(k) Clearance

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

K882391 · Ela Medical, Inc. · Cardiovascular device
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Nov 1988
Decision
157d
Days
Class 3
Risk

K882391 is an FDA 510(k) clearance for the OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 14, 1988 after a review of 157 days - an extended review 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 K882391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1988
Decision Date November 14, 1988
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
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 K882391.
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · Medtronic Vascular · Aug 1989
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · Medtronic Vascular · Nov 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215 · Medtronic Vascular · Nov 1988
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · Intermedics, Inc. · Nov 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · Medtronic Vascular · Aug 1987