Cleared Traditional

K022360 - ERA 3000

Also marketed or referenced as:
PA-2 IS-1 ADAPTER EK-4-N PACEMAKER TEST CABLE ERA 3000 CHARGER ERA 3000 BATTERY (TYPE 2) NK-11 POWER SUPP.

K022360 is an FDA 510(k) clearance for ERA 3000, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DTA cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K022360 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
192d
Days
Class 2
Risk

K022360 is an FDA 510(k) clearance for the ERA 3000. 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 January 27, 2003 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3720 - 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 - K022360

510(k) Number K022360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date January 27, 2003
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DTA Tester, Pacemaker Electrode Function

All 7
Devices cleared under the same product code (DTA) and FDA review panel - the closest regulatory comparables to K022360.
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230 · Biotronik, Inc. · Dec 2007
ADAPTER CABLE
K050884 · Remington Medical, Inc. · May 2005
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · Biotronik, Inc. · Dec 2003
SIEMENS-ELEMA PSA 376
K812104 · Siemens Corp. · Dec 1981
VA 1000
K791380 · Vitatron Medical BV · Sep 1979
CARDIOTEST 2200
K790503 · Cardiac Pacemakers, Inc. · May 1979