Cleared Traditional

K840748 - LITHIUM PACEMAKER 811-811L & 811XL

K840748 is an FDA 510(k) clearance for LITHIUM PACEMAKER 811-811L & 811XL, manufactured by Omikron Scientific, Ltd.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K840748 · Omikron Scientific, Ltd. · Cardiovascular device
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Aug 1984
Decision
162d
Days
Class 3
Risk

K840748 is an FDA 510(k) clearance for the LITHIUM PACEMAKER 811-811L & 811XL. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Omikron Scientific, Ltd. (Walker, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 162 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 Omikron Scientific, Ltd. devices

FDA 510(k) Submission Details - K840748

510(k) Number K840748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date August 03, 1984
Days to Decision 162 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 125d · This submission: 162d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K840748.
MEDTRONIC 5984-5984LP-5985
K843837 · Medtronic Vascular · Oct 1984
MEDTRONIC 8437/8438
K843089 · Medtronic Vascular · Aug 1984
NEOS LP
K841633 · Biotronik Sales, Inc. · Aug 1984
LEPTOS
K841635 · Biotronik Sales, Inc. · Aug 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · Cook Pacemaker Corp. · Jul 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983 · Cook Pacemaker Corp. · Jul 1984