PMA P160022S050

Device: CPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep
Applicant: ZOLL Medical Corporation
PMA number: P160022
Supplement: S050
Product code: MKJ
Decision date: 2026-04-28
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: approval to add 16 models of currently approved ZOLL electrodes as compatible accessories for the Zenix Monitor/Defibrillator

Current openFDA PMA Record#

Device: CPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep
Applicant: ZOLL Medical Corporation
PMA number: P160022
Supplement: S050
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-04-28
Decision code: APPR
Date received: 2026-01-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval to add 16 models of currently approved ZOLL electrodes as compatible accessories for the Zenix Monitor/Defibrillator