Cleared Traditional

K853567 - DJP UNIPOLAR

K853567 is an FDA 510(k) clearance for DJP 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 254-day FDA review.

K853567 · Biotronik Sales, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
254d
Days
Class 3
Risk

K853567 is an FDA 510(k) clearance for the DJP 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 May 7, 1986 after a review of 254 days - an extended review 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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K853567

510(k) Number K853567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date May 07, 1986
Days to Decision 254 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
129d slower than avg
Panel avg: 125d · This submission: 254d
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 K853567.
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · Pacesetter Systems · May 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · Pacesetter Systems · May 1986
DJ UNIPOLAR
K853566 · Biotronik Sales, Inc. · May 1986
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER
K861176 · Intermedics, Inc. · Apr 1986
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
K861110 · Intermedics, Inc. · Apr 1986
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985 · Intermedics, Inc. · Mar 1986