# ZOLL Medical Corporation

- Location (FDA's records): Chelsmford, MA
- FDA decisions: 69 (1991–2024): 63 510(k) clearances and 6 original PMA approvals
- Names in FDA's records: ZOLL Medical Corporation (36); Zoll Medical Corp (33)
- Product codes: MKJ (39), LDD (9), DXJ (3), DTE (2), DXN (2), MHX (2), FRN (2), CBK (2), LSZ (1), PIZ (1), MWI (1), DSK (1)
- 510(k) review time since 2016: median 295 days, against 203 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 60 (31 its own); citations of its devices by later devices: 64 (31 its own)
- Recalls linked to its devices: 32 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zoll Medical Corporation, World Wide Headquarters: 8 (https://510kreport.com/company/zoll-medical-world-wide-headquarters)
- Bio-Detek, Inc.: 3 (https://510kreport.com/company/bio-detek)
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)
- Impact Instrumentation, Inc.: 2 (https://510kreport.com/company/impact-instrumentation)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Medtronic Physio-Control Corp.: 1 (https://510kreport.com/company/medtronic-physio-control)
- Zmi Corp.: 1 (https://510kreport.com/company/zmi)
- Cardiac Science Corporation: 1 (https://510kreport.com/company/cardiac-science)

## Firms that cite its devices most
- Zoll Medical Corporation, World Wide Headquarters: 12 (https://510kreport.com/company/zoll-medical-world-wide-headquarters)
- Philips Medical Systems, Inc.: 4 (https://510kreport.com/company/philips-medical-systems)
- Bio-Detek, Inc.: 3 (https://510kreport.com/company/bio-detek)
- Express MD Solutions, LLC: 2 (https://510kreport.com/company/express-md-solutions)
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Athena Gtx: 1 (https://510kreport.com/company/athena-gtx)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Innovision A/S: 1 (https://510kreport.com/company/innovision-a-s)

## Its most-cited devices
- K042007: Zoll E Series Defibrillator (2005), cited by 9
- K032363: Zoll M Series Nibp Option (2003), cited by 6
- K033474: Zoll Aed Plus (2004), cited by 5
- K060559: Zoll R Series Defibrillator (2006), cited by 5
- K103473: Zoll Rescuenet Epcr Model Rescuenet Epcr (2011), cited by 3
- K110742: Onestep Adult Multi-Function Electrode (2011), cited by 3

## Recent decisions
- K233486: 731 Series Ventilator (Dec 13, 2024)
- K202375: ZOLL Propaq M (Mar 9, 2021)
- P160033: Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 (Dec 7, 2018)
- P160034: Powerheart® AED G3 Pro (Dec 6, 2018)
- K180482: ZOLL Propaq M (Nov 30, 2018)
- K172653: Power Infuser (Jul 18, 2018)
- P160022: X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ (Dec 27, 2017)
- K162832: 731 Series Ventilators (Aug 2, 2017)

Source page: https://510kreport.com/company/zoll-medical