Cleared Traditional

K023205 - ELOX P 45-BP

Also marketed or referenced as:
ELOX P 53-BP ELOX P 60-BP

K023205 is the FDA 510(k) clearance for ELOX P 45-BP by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K023205 · Biotronik, Inc. · Cardiovascular device
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Apr 2003
Decision
211d
Days
Class 3
Risk

K023205 is an FDA 510(k) clearance for the ELOX P 45-BP. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 211 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, Inc. devices

Submission Details

510(k) Number K023205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 25, 2002
Decision Date April 24, 2003
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 352
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K023205.
PERMANENT PACING LEAD, MODEL PY2
K041809 · Oscor, Inc. · Aug 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · Oscor, Inc. · Apr 2004
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · Oscor, Inc. · Jan 2003
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · Biotronik, Inc. · Dec 2002
AROX 45-JBP
K023099 · Biotronik, Inc. · Oct 2002