Cleared Traditional

K970072 - OPUS S MODEL 4121 AND 4124 PACEMAKERS

K970072 is the FDA 510(k) clearance for OPUS S MODEL 4121 AND 4124 PACEMAKERS by Ela Medical, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K970072 · Ela Medical, Inc. · Cardiovascular device
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Aug 1997
Decision
233d
Days
Class 3
Risk

K970072 is an FDA 510(k) clearance for the OPUS S MODEL 4121 AND 4124 PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 233 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 K970072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 08, 1997
Decision Date August 29, 1997
Days to Decision 233 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
108d slower than avg
Panel avg: 125d · This submission: 233d
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 K970072.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · Biotronik, Inc. · Nov 1999
PIKOS LP 01, PIKOS LP E01
K945627 · Biotronik, Inc. · Mar 1996
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · Medtronic Vascular · Dec 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · Medtronic Vascular · Dec 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · Biotronik, Inc. · Sep 1995
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417 · Cook Pacemaker Corp. · Sep 1995