Product code DRN— Cardiovascular
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
- Classification name
- Device, Counter-Pulsating, External
- Device class
- Class 2
- Regulation
- 21 CFR 870.5225
- Advisory panel
- Cardiovascular
- Total cleared
- 34
- First cleared
- Most recent
Market context for product code DRN
FDA has cleared devices under product code DRN between 1980 and 2025, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2020
- 2019
- 2018
- 2015
- 2013
- 2009
- 2008
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code DRN
Recent clearances under product code DRN
- K250756 — Pression Wave PRO External Counter-Pulsation System
- K202108 — External Counterpulsation System, Soulaire
- K191955 — Enhanced External Counter Pulsation Device Plus Omay-A
- K190683 — External Counterpulsation System
- K173483 — Pure Flow External Counter-Pulsation Device
- K152115 — Renew NCP-5 External Counterpulsation System
- K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
- K082134 — CIRCULATOR BOOT
- K081359 — GENESIS ECP
- K052611 — ECP HEALTH SYSTEM, MODEL 2005
- K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
- K042413 — ACS MODEL NCP-2
- K033617 — EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
- K033657 — MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
- K030587 — EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
- K030532 — CPCA2000 COUNTERPULSATION SYSTEM
- K021340 — AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
- K023701 — ANGIONEW-IV
- K022078 — SOLA, COUNTER-PULSATION, MODEL SECP-S
- K023427 — CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
- K023016 — NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
- K022107 — CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
- K020857 — EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
- K012141 — AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
- K010261 — CARDIOMEDICS ECP SYSTEM
- K003469 — EECP THERAPY SYSTEM, MODEL TS3
- K980937 — NICORE MODEL ESP -1
- K971026 — THE CIRCULATOR BOOT
- K940264 — VASOGENICS EECP-MC2
- K882401 — STONY BROOK MODEL EECP-MC1
- K872034 — CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
- K833627 — CIRCULATOR MINIBOOT
- K792430 — CARDIASSIST EXTERNAL COUNTERPULSATION
- K792354 — THE CIRCULATOR BOOT
Data sourced from openFDA. This site is unofficial and independent of the FDA.