Cleared Traditional

K844277 - OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR

K844277 is an FDA 510(k) clearance for OMIKRON PACEMAKER 837 UNIPOLAR & 838 BI..., manufactured by Omikron Scientific, Ltd.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K844277 · Omikron Scientific, Ltd. · Cardiovascular device
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Feb 1985
Decision
102d
Days
Class 2
Risk

K844277 is an FDA 510(k) clearance for the OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Omikron Scientific, Ltd. (Israel, IL). The FDA issued a Cleared decision on February 15, 1985 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K844277

510(k) Number K844277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1984
Decision Date February 15, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K844277.
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COMPUTER
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K843555 · Gould, Inc. · Feb 1985
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