Cleared Traditional

K994240 - EX 45-BP, MODEL 330 132

Also marketed or referenced as:
EX 53-BP, MODEL 130 018 EX 60-BP, MODEL 330 133

K994240 is an FDA 510(k) clearance for EX 45-BP, manufactured by Biotronik, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K994240 · Biotronik, Inc. · Cardiovascular device
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Apr 2000
Decision
119d
Days
Class 3
Risk

K994240 is an FDA 510(k) clearance for the EX 45-BP, MODEL 330 132. 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 13, 2000 after a review of 119 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, Inc. devices

FDA 510(k) Submission Details - K994240

510(k) Number K994240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 16, 1999
Decision Date April 13, 2000
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K994240.
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · Oscor, Inc. · May 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · Biotronik, Inc. · Jan 2001
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · Biotronik, Inc. · Jun 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
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
K000763 · Biotronik, GmbH & Co. · 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