Cleared Traditional

K841451 - BIOTRONIK DY-UNIPOLAR

K841451 is an FDA 510(k) clearance for BIOTRONIK DY-UNIPOLAR, manufactured by Biotronik Sales, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K841451 · Biotronik Sales, Inc. · Cardiovascular device
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Feb 1985
Decision
304d
Days
Class 2
Risk

K841451 is an FDA 510(k) clearance for the BIOTRONIK DY-UNIPOLAR. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik Sales, Inc. (Lake Oswego, 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

FDA 510(k) Submission Details - K841451

510(k) Number K841451 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
Combination Product No
PCCP Authorized No
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.

DTD Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K841451.
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · Pacesetter Systems · Mar 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · Pacesetter Systems · Feb 1985
BIOTRONIK DNP UNIPOLAR
K841450 · Biotronik Sales, Inc. · Feb 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