Cleared Traditional

K833519 - PULSE GENERATOR MODEL 688

K833519 is the FDA 510(k) clearance for PULSE GENERATOR MODEL 688 by Burditt & Calkins-Siemens-Elema. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K833519 · Burditt & Calkins-Siemens-Elema · Cardiovascular device
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Jan 1984
Decision
111d
Days
Class 3
Risk

K833519 is an FDA 510(k) clearance for the PULSE GENERATOR MODEL 688. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Burditt & Calkins-Siemens-Elema (Walker, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 111 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 Burditt & Calkins-Siemens-Elema devices

Submission Details

510(k) Number K833519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date January 30, 1984
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
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 252
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K833519.
PACEMAKER 147 VVI-THE OPTINIA
K840701 · Telectronics, Inc. · May 1984
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K833427 · Telectronics, Inc. · Feb 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · Telectronics, Inc. · Feb 1984
IMPLANTABLE PULSE GENERATOR
K834096 · Intermedics, Inc. · Dec 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · Telectronics, Inc. · Dec 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914 · Intermedics, Inc. · Nov 1983