Atlas FDA

ZOLL PROPAQ XM

FDA 510(k) clearance K121367 · decided 2012-06-21

Clearance details

K-number
K121367
Device name
ZOLL PROPAQ XM
Applicant
ZOLL Medical Corporation
Decision
Substantially Equivalent
Date received
2012-05-07
Decision date
2012-06-21
Days to decision
45 days
Clearance type
Traditional
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chelsmford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Softw recall (Z-1311-2014)ZOLL Medical Corporation2014-03-31

PMA approvals by this applicant

RecordFirmDate
OneStep CPR Complete Electrode (P160022/S049)ZOLL Medical Corporation2025-12-30
AED 3™ (P160015/S025)ZOLL Medical Corporation2025-12-18
X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators (P160022/S046)ZOLL Medical Corporation2025-12-18
ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048)ZOLL Medical Corporation2025-12-09
ZOLL Zenix® Monitor/Defibrillator (P160022/S036)ZOLL Medical Corporation2025-09-29
CPR Uni-padz Electrode (P160022/S047)ZOLL Medical Corporation2025-09-22
CPR-D-padz Electrode (P160015/S026)ZOLL Medical Corporation2025-09-22
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042)ZOLL Medical Corporation2025-08-28