Cleared Traditional

K831859 - PACEMAKER PROGRAMMER #2032

K831859 is an FDA 510(k) clearance for PACEMAKER PROGRAMMER #2032, manufactured by Vitatron Medical BV. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K831859 · Vitatron Medical BV · Cardiovascular device
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Oct 1983
Decision
139d
Days
Class 3
Risk

K831859 is an FDA 510(k) clearance for the PACEMAKER PROGRAMMER #2032. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Vitatron Medical BV (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 139 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 Vitatron Medical BV devices

FDA 510(k) Submission Details - K831859

510(k) Number K831859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1983
Decision Date October 27, 1983
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 388
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K831859.
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · Telectronics, Inc. · Dec 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914 · Intermedics, Inc. · Nov 1983
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199 · Intermedics, Inc. · Oct 1983
GENERATOR, PULSE, PACEMAKER #532
K831860 · Vitatron Medical BV · Oct 1983
SILICONE RUBBER ISOLATION SLEEVE 351-01
K833198 · Intermedics, Inc. · Oct 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · Intermedics, Inc. · Oct 1983