Cleared Traditional

BIOTRONIK DNP UNIPOLAR (K841450) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841450 · Biotronik Sales, Inc. · Cardiovascular device
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Feb 1985
Decision
304d
Days
Class 2
Risk

K841450 is an FDA 510(k) clearance for the BIOTRONIK DNP UNIPOLAR. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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. Elevated predicate reliance 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 Biotronik Sales, Inc. devices

Submission Details

510(k) Number K841450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date February 07, 1985
Days to Decision 304 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 125d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 37
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K841450.
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · Intermedics, Inc. · Jul 1985
MEDTRONIC 5064
K851890 · Medtronic Vascular · Jun 1985
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
K844974 · Medtronic Vascular · Mar 1985
MEDTRONIC MODEL 6912
K844687 · Medtronic Vascular · Feb 1985
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · Medtronic Vascular · Jan 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · Medtronic Vascular · Jan 1985