ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci
FDA premarket approval P160022/S048 · decided 2025-12-09
Approval details
- PMA number
- P160022
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- ZOLL Medical Corporation
- Date received
- 2025-09-30
- Decision date
- 2025-12-09
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- Design changes to the Zenix Multi-Function Cable (MFC) and to reintroduce the Zenix CPR Complete, ZOLL OneStep Complete, and ZOLL OneStep Pacing electrodes as Zenix-compatible accessories
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
| ZOLL Propaq M (K202375) | ZOLL Medical Corporation | 2021-03-09 |
| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
| Power Infuser (K172653) | ZOLL Medical Corporation | 2018-07-18 |
| 731 Series Ventilators (K162832) | ZOLL Medical Corporation | 2017-08-02 |
| Model 330 Multifunction Aspirator (K170533) | ZOLL Medical Corporation | 2017-04-18 |
| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |