Cleared Traditional

K882391 - OPUS 3 PULSE GENERATORS MODELS 4003

K882391 is the FDA 510(k) clearance for OPUS 3 PULSE GENERATORS MODELS 4003 by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

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
Combination Product No
PCCP Authorized No
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K882391.
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · Ela Medical, Inc. · Jan 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
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427 · Ela Medical, Inc. · Sep 1988
PROLOG MP 658M PULSE GENERATOR
K883087 · Pacesetter Systems · Sep 1988
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474 · Ela Medical, Inc. · Sep 1988