Cleared Traditional

K882474 - OPUS PULSE GENERATORS MODELS 2001

K882474 is the FDA 510(k) clearance for OPUS PULSE GENERATORS MODELS 2001 by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K882474 · Ela Medical, Inc. · Cardiovascular device
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Sep 1988
Decision
89d
Days
Class 3
Risk

K882474 is an FDA 510(k) clearance for the OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004. 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 September 12, 1988 after a review of 89 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 K882474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1988
Decision Date September 12, 1988
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K882474.
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391 · Ela Medical, Inc. · 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 3001, 3003 AND 3004
K882476 · Ela Medical, Inc. · Sep 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · Telectronics, Inc. · Jul 1988
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · Intermedics, Inc. · Nov 1987