Cleared Traditional

K894065 - OPUS MODEL 4001

K894065 is the FDA 510(k) clearance for OPUS MODEL 4001 by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K894065 · Ela Medical, Inc. · Cardiovascular device
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Sep 1989
Decision
110d
Days
Class 3
Risk

K894065 is an FDA 510(k) clearance for the OPUS MODEL 4001. 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 26, 1989 after a review of 110 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 K894065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date September 26, 1989
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 K894065.
MODIFIED MODEL 5401B TEST CABLE
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K896809 · Medtronic Vascular · Jan 1990
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · Medtronic Vascular · Sep 1989
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, Inc. · Sep 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · Telectronics, Inc. · Sep 1989