Cleared Traditional

K993139 - YP 45/15-BP

Also marketed or referenced as:
YP 53/15-BP YP 60/15-BP

K993139 is the FDA 510(k) clearance for YP 45/15-BP by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993139 · Biotronik, Inc. · Cardiovascular device
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Dec 1999
Decision
88d
Days
Class 3
Risk

K993139 is an FDA 510(k) clearance for the YP 45/15-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 December 17, 1999 after a review of 88 days - a notably fast clearance 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 K993139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 20, 1999
Decision Date December 17, 1999
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K993139.
EX 45-BP, MODEL 330 132
K994240 · Biotronik, Inc. · Apr 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K993448 · Ela Medical, Inc. · Apr 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K000029 · Ela Medical, Inc. · Apr 2000
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · Biotronik, Inc. · Jul 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · Biotronik, Inc. · Jun 1999
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
K980869 · Biotronik, Inc. · Sep 1998