Cleared Traditional

K853568 - DNR UNIPOLAR

K853568 is an FDA 510(k) clearance for DNR UNIPOLAR, manufactured by Biotronik Sales, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K853568 · Biotronik Sales, Inc. · Cardiovascular device
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Jan 1986
Decision
142d
Days
Class 3
Risk

K853568 is an FDA 510(k) clearance for the DNR UNIPOLAR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on January 15, 1986 after a review of 142 days - within the typical 510(k) review window.

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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K853568

510(k) Number K853568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date January 15, 1986
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K853568.
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · Intermedics, Inc. · Mar 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918 · Intermedics, Inc. · Mar 1986
OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE
K854128 · Oscor Medical Corp. · Feb 1986
STYLET INTRODUCER FUNNEL
K854142 · Telectronics, Inc. · Jan 1986
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446 · Cardiac Control Systems, Inc. · Jan 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · Medtronic Vascular · Jan 1986