Cleared Special

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K033613) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033613 · Biotronik, Inc. · Cardiovascular device
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Dec 2003
Decision
21d
Days
Class 2
Risk

K033613 is an FDA 510(k) clearance for the MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER. Classified as Tester, Pacemaker Electrode Function (product code DTA), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 8, 2003 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3720 - 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.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K033613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2003
Decision Date December 08, 2003
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTA Tester, Pacemaker Electrode Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3720
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.