Cleared Special

K042708 - ERA 3000 PACING SYSTEM ANALYZER

K042708 is an FDA 510(k) clearance for ERA 3000 PACING SYSTEM ANALYZER, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Special 510(k) pathway after a 20-day FDA review.

K042708 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
20d
Days
Class 2
Risk

K042708 is an FDA 510(k) clearance for the ERA 3000 PACING SYSTEM ANALYZER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042708

510(k) Number K042708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2004
Decision Date October 20, 2004
Days to Decision 20 days
Submission Type Special
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
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 63
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K042708.
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · Medtronic, Inc. · Feb 2015
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
PSA SERIES
K123916 · Osypka Medical, Inc. · Apr 2013
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
K033130 · Osypka Medical, Inc. · Oct 2003
GALIX PACESTAR
K023080 · Galix Biomedical Instrumentation, Inc. · Jun 2003
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
K022939 · Osypka Medical, Inc. · Oct 2002
K042708 · ERA 3000 PACING SYSTEM ANALYZER
Download PDF FDA Summary Biotronik, Inc.