Data / Medical devices / United States / Zoll Medical Corporation
Zoll Medical Corporation: FDA-registered device maker in Wilmington, MA, United States, 8 510(k) clearances and 2 PMA approvals
Zoll Medical Corporation is registered with the FDA (registration 3038259592) in Wilmington, MA, United States. It lists 12 device types. The FDA files 8 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038259592
- Address
- 38 Upton Dr, Wilmington, MA, United States, 01887
- Owner or operator
- ZOLL Medical Corporation (1220908)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 17, 2017
- Registered through
- 2026
- Brand names listed
- 731 Series, ACCUVENT SENSOR DISPOSABLE, AEV, EMV+, Eagle II, FLOW SENSOR CONNECTOR, ACCUVENT, FLOWTUBE, ACCUVENT, Z Vent
Devices it lists
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 |
| 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 |
| March 18, 2009 | K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | CBK | Substantially Equivalent | Pulmonetic Systems, Inc. | accessdata.fda.gov |
| May 25, 2006 | K060647 | LTV 1200 VENTILATOR | CBK | Substantially Equivalent | Pulmonetic Systems, Inc. | accessdata.fda.gov |
| June 3, 2004 | K040790 | MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS | CBK | Substantially Equivalent | Pulmonetic 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 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 |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Transducer, Gas Flow
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Continuous Measurement Thermometer
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated October 16, 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.