Cleared Special

K033657 - MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

K033657 is an FDA 510(k) clearance for MOBILE EXTERNAL COUNTER PULSATION SYSTE..., manufactured by Living Data Technologies Corporation. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Special 510(k) pathway after a 28-day FDA review.

K033657 · Living Data Technologies Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
28d
Days
Class 2
Risk

K033657 is an FDA 510(k) clearance for the MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Living Data Technologies Corporation (Great Neck, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 - K033657

510(k) Number K033657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date December 19, 2003
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DRN Device Classification - Class 2, Special Controls

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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 - DRN Device, Counter-pulsating, External

All 31
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K033657.
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
K050172 · Cardiomedics, Inc. · Mar 2005
ACS MODEL NCP-2
K042413 · Applied Cardiac Systems · Dec 2004
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
K033617 · Vasomedical, Inc. · Mar 2004
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · S-Tct Health, Inc. · May 2003
CPCA2000 COUNTERPULSATION SYSTEM
K030532 · Cpca2000, Inc. · Mar 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · External Counterpulsation Lab · Jan 2003
K033657 · MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
Download PDF FDA Summary Living Data Technolog…