Data / Medical devices / United States / Zoll Medical Corporation
Zoll Medical Corporation: FDA-registered device maker in Chelmsford, MA, United States, 22 510(k) clearances and 7 PMA approvals
Zoll Medical Corporation is registered with the FDA (registration 1220908) in Chelmsford, MA, United States. It lists 29 device types. The FDA files 22 510(k) clearances and 7 PMA approvals under its listings, the newest dated December 13, 2024. 20 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220908
- Address
- 269 Mill Road, Chelmsford, MA, United States, 01824
- Owner or operator
- ZOLL Medical Corporation (1220908)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 19, 2008
- Registered through
- 2026
- Brand names listed
- 731 Series, ACCUVENT SENSOR DISPOSABLE, AEV, EMV+, Eagle II, FLOW SENSOR CONNECTOR, ACCUVENT, FLOWTUBE, ACCUVENT, MRI Roll Stand and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Cardiopulmonary Resuscitation | LIX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve | PIZ | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Display, Cathode-Ray Tube, Medical | DXJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Kit, First Aid, Talking | OVR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Gas Flow | BXP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, High Frequency | LSZ | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wearable Automated External Defibrillator | MVK | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2024 | K233486 | 731 Series Ventilator | CBK | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| November 10, 2021 | K201082 | LTV2 Series Ventilators | CBK | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| March 9, 2021 | K202375 | ZOLL Propaq M | MWI | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| September 13, 2019 | K183364 | Bellavista | CBK | Substantially Equivalent | Imtmedical AG | accessdata.fda.gov |
| July 18, 2018 | K172653 | Power Infuser | FRN | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| August 2, 2017 | K162832 | 731 Series Ventilators | CBK | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| April 18, 2017 | K170533 | Model 330 Multifunction Aspirator | BTA | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| April 3, 2014 | K132488 | ZOLL CODE WRITER | DXJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| December 17, 2013 | K131919 | ZOLL EPCR IOS | DXJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| October 3, 2012 | K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | DXQ | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| March 21, 2012 | K112432 | ZOLL X SERIES | MKJ | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| September 15, 2010 | K102174 | ZOLL PROPAQ M | DRT | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| July 29, 2010 | K100654 | ZOLL PROPAQ MD | LDD | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| March 18, 2009 | K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | CBK | Substantially Equivalent | Pulmonetic Systems, Inc. | accessdata.fda.gov |
| February 28, 2007 | K062537 | ZOLL M SERIES WITH REAL CPR HELP | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| August 17, 2006 | K060559 | ZOLL R SERIES DEFIBRILLATOR | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| May 25, 2006 | K060647 | LTV 1200 VENTILATOR | CBK | Substantially Equivalent | Pulmonetic Systems, Inc. | accessdata.fda.gov |
| August 3, 2005 | K050994 | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | BZD | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| February 4, 2005 | K041892 | ZOLL AED PRO EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| October 26, 2004 | K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | LDD | Substantially Equivalent | Zoll Medical Corp | accessdata.fda.gov |
| June 3, 2004 | K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | CBK | Substantially Equivalent | Pulmonetic Systems, Inc. | accessdata.fda.gov |
| November 20, 2003 | K033401 | MODIFICATION TO RESQPOD CIRCULATORY ENHANCER | BWF | Substantially Equivalent | Advanced Circulatory Systems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 7, 2018 | P160033 | Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 | MKJ | 9 | April 28, 2026 | accessdata.fda.gov |
| December 6, 2018 | P160034 | Powerheart® AED G3 Pro | MKJ | 2 | March 1, 2020 | accessdata.fda.gov |
| December 27, 2017 | P160022 | X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower | MKJ | 52 | October 16, 2026 | accessdata.fda.gov |
| May 26, 2017 | P160015 | AED Plus and Fully Automatic AED Plus | MKJ | 27 | October 16, 2026 | accessdata.fda.gov |
| March 6, 2015 | P110024 | RESQCPR SYSTEM | PIZ | 5 | August 27, 2026 | accessdata.fda.gov |
| December 18, 2001 | P010030 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | MVK | 198 | October 6, 2026 | accessdata.fda.gov |
| March 29, 1991 | P890057 | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | LSZ | 22 | July 23, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 13, 2025 | 96198 | Class II | Ongoing | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerhea | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | accessdata.fda.gov |
| April 30, 2024 | 94589 | Class I | Ongoing | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy | accessdata.fda.gov |
| June 12, 2019 | 83109 | Class II | Ongoing | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitori | There is a potential for the device to fail to deliver energy to the patient. | accessdata.fda.gov |
| August 4, 2017 | 79204 | Class II | Terminated | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: D | A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator pos | accessdata.fda.gov |
| June 30, 2017 | 79248 | Class II | Terminated | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing;:: 5 kg with acute or chronic respiratory fail | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. | accessdata.fda.gov |
| March 5, 2014 | 67749 | Class II | Terminated | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used | accessdata.fda.gov |
| August 16, 2012 | 63004 | Class II | Terminated | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of p | Shipped with incorrect software | accessdata.fda.gov |
| March 30, 2012 | 62736 | Class III | Terminated | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers. | A shipment mix-up took place. | accessdata.fda.gov |
| March 19, 2012 | 62535 | Class III | Terminated | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuou | Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. | accessdata.fda.gov |
| November 4, 2011 | 60786 | Not yet classified | Terminated | Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents. | A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device. | accessdata.fda.gov |
| October 19, 2011 | 60767 | Not yet classified | Terminated | Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator | Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k). | accessdata.fda.gov |
| May 27, 2011 | 59400 | Not yet classified | Terminated | Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations | Model 754/754 M Disposable MRI Ventilator Circuits are being distributed without market clearence (510k). | accessdata.fda.gov |
| April 21, 2011 | 58600 | Not yet classified | Terminated | Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy | accessdata.fda.gov |
| March 24, 2010 | 55115 | Not yet classified | Terminated | ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rh | Device issued Shock Advised message but failed to auto-charge the defibrillator. | accessdata.fda.gov |
| August 31, 2009 | 53162 | Not yet classified | Terminated | ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically signi | Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy. | accessdata.fda.gov |
| February 12, 2009 | 51053 | Not yet classified | Terminated | Zoll AED Plus Defibrillator | Device fails to discharge the defibrillation energy. | accessdata.fda.gov |
| January 15, 2008 | 46408 | Not yet classified | Terminated | Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824. | Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct. | accessdata.fda.gov |
| August 2, 2004 | 29959 | Not yet classified | Terminated | Zoll M Series Automated Defibrillator (AED) | Visual Sreen display and audible prompt may not advise to 'Press Shock' | accessdata.fda.gov |
| June 23, 2003 | 26590 | Not yet classified | Terminated | Zoll M Series External Defibrillator | Defibrillator may fail to charge or hold its charge above energies of 75 joules | accessdata.fda.gov |
| December 17, 2002 | 25245 | Not yet classified | Terminated | Zoll AED Plus Defibrillator (Automatic External Defibrillator) | Defibrillator may fail to function due to false detection of safety fault condition | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, First Aid, Talking
- All makers of Strap, Head, Gas Mask
- All makers of Automated External Defibrillators (Non-Wearable)
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of Oximeter
Updated April 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.