Cleared Traditional

K822239 - COAXIAL BIPOLAR PACING ELECTRODE

K822239 is an FDA 510(k) clearance for COAXIAL BIPOLAR PACING ELECTRODE, manufactured by Burditt & Calkins-Siemens-Elema. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K822239 · Burditt & Calkins-Siemens-Elema · Cardiovascular device
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Oct 1982
Decision
68d
Days
Class 3
Risk

K822239 is an FDA 510(k) clearance for the COAXIAL BIPOLAR PACING ELECTRODE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Burditt & Calkins-Siemens-Elema (Mchenry, US). The FDA issued a Cleared decision on October 4, 1982 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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

FDA 510(k) Submission Details - K822239

510(k) Number K822239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1982
Decision Date October 04, 1982
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K822239.
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · Oscor, Inc. · Dec 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · Oscor, Inc. · Dec 1982
MEDTRONIC MODELS 4011 & 4511
K822781 · Medtronic Vascular · Nov 1982
MEDTRONIC #6993
K820989 · Medtronic Vascular · Aug 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · Pacesetter Systems · Aug 1982