Cleared Traditional

K083674 - PK-141 PATIENT CABLE

K083674 is an FDA 510(k) clearance for PK-141 PATIENT CABLE, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K083674 · Biotronik, Inc. · Cardiovascular device
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Apr 2009
Decision
111d
Days
Class 2
Risk

K083674 is an FDA 510(k) clearance for the PK-141 PATIENT CABLE. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K083674

510(k) Number K083674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2008
Decision Date April 01, 2009
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTC Analyzer, Pacemaker Generator Function

All 25
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K083674.
PSA Cable
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MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · Pace Medical · Oct 2000
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · North American Technical Services Corp. · Nov 1996
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · Bio-Tek Instruments, Inc. · Jun 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · Medtronic Vascular · May 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · Seamed Corp. · Mar 1991