Aid, Cardiopulmonary Resuscitation
Cardiovascular · 21 CFR 870.5210
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software
Recent MDR events
153 adverse event reports on file
- CARDIOPULMONARY RESUSCITATIONNov 5, 2025MalfunctionSchiller Ag3003832357-2025-000832
- ONESTEPSep 5, 2025MalfunctionZoll Medical Corporation22976654
- ONESTEPJul 15, 2025MalfunctionZoll Medical Corporation22507541
- ONESTEPMay 21, 2025MalfunctionZoll Medical Corporation22060232
- ONESTEPMar 14, 2025InjuryZoll Medical Corporation21604451
- ONESTEPJan 22, 2025MalfunctionZoll Medical Corporation21207198
- ONESTEPJan 17, 2025MalfunctionZoll Medical Corporation21178420
- ONESTEPSep 16, 2024MalfunctionZoll Medical Corporation20223998
- ONESTEPSep 16, 2024MalfunctionZoll Medical Corporation20224002
- ONESTEP CPR AAJun 14, 2024MalfunctionZoll Medical Corporation19536385
Event type breakdown
Recalls
2 recall events for this product code
- Philips Electronics North America CorporationTerminatedFeb 22, 2018
Philips QCPR Meter - used with FR3
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Z-0683-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedFeb 22, 2018
Philips QCPR Meter - used with MRx
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Z-0684-2018 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Cbr Enterprise Limited
Hong Kong, HK
Dhl Supply Chain (netherlands) B.v.
Beringe Limburg, NL
Amphenol Alden Products Company
Hermosillo Sonora, MX
Philips Electronics Ltd
Mississauga Ontario, CA
Infusystem Inc.
Lenexa, KS, US
Katecho Llc
DES MOINES, IA, US
Amphenol Cable And Interconnect Technologies Asia Pacific Ltd.
Tsimshatsui, Kowloon, HK
Laerdal Medical A/s
STAVANGER Rogaland, NO
Ad Supply Group Limited
London London, City of, GB
Laerdal Medical As, Stavanger Manufacturing
Sandnes Rogaland, NO
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Tribalco
Tampa, FL, US
Quipment
Nancy Meurthe-et-Moselle, FR
Remote Diagnostic Technologies Ltd.
FARNBOROUGH Hampshire, GB
Zoll Medical Corporation
CHELMSFORD, MA, US
Platinum Focus Group Ltd.
London London, City of, GB
Schiller Ag
BAAR Zug, CH
510(k) clearances
17 clearances for this product code
- CredoMar 6, 2021
K201581 · CPR BAND
- Laerdal Medical ASDec 17, 2018
K183348 · Reusable Silicone Cover CPRmeter 2
- Laerdal Medical ASMar 23, 2018
K173886 · CPRmeter 2 CPR Feedback Device
- Laerdal Medical ASAug 13, 2015
K151702 · Reusable Full Silicone Cover
- Avantech, Inc.Dec 10, 2013
K123248 · CPR RSQ ASSIST
- Physio-Control, Inc.Apr 17, 2013
K123597 · TRUECPR COACHING DEVICE
- Laerdal Medical A/SOct 22, 2012
K122050 · CPRMETER CPR FEEDBACK DEVICE
- Zoll Medical CorpMay 10, 2012
K112660 · POCKETCPR