Cleared Traditional

K900461 - OPUS MODEL 4021, VVI, 5MM UNIPOLAR

K900461 is an FDA 510(k) clearance for OPUS MODEL 4021, manufactured by Ela Medical, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K900461 · Ela Medical, Inc. · Cardiovascular device
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Mar 1990
Decision
42d
Days
Class 3
Risk

K900461 is an FDA 510(k) clearance for the OPUS MODEL 4021, VVI, 5MM UNIPOLAR. 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 March 14, 1990 after a review of 42 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

FDA 510(k) Submission Details - K900461

510(k) Number K900461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1990
Decision Date March 14, 1990
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K900461.
MINIX, MINIX ST, NEW IC: L74
K902134 · Medtronic Vascular · Jul 1990
MODIFIED MODEL 5401B TEST CABLE
K900622 · Medtronic Vascular · Apr 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116 · Telectronics Pacing Systems, Inc. · Mar 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · Medtronic Vascular · Jan 1990
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494 · Biotronik, GmbH & Co. · Oct 1989
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989