Company ยท US
ZOLL Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2024. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
19recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 51 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 9 |
| CBK | Ventilator, Continuous, Facility Use | 4 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 |
| DTE | Pulse-Generator, Pacemaker, External | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| FRN | Pump, Infusion | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 |
| MKT | Hepatitis Viral B Dna Detection | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2024 | K233486 | 731 Series Ventilator ZOLL Medical Corporation | CBK |
| Mar 9, 2021 | K202375 | ZOLL Propaq M ZOLL Medical Corporation | MWI |
| Nov 30, 2018 | K180482 | ZOLL Propaq M ZOLL Medical Corporation | MHX |
| Jul 18, 2018 | K172653 | Power Infuser ZOLL Medical Corporation | FRN |
| Aug 2, 2017 | K162832 | 731 Series Ventilators ZOLL Medical Corporation | CBK |
| Apr 18, 2017 | K170533 | Model 330 Multifunction Aspirator ZOLL Medical Corporation | BTA |
| Dec 3, 2014 | K142915 | ZOLL X Series ZOLL Medical Corporation | MKJ |
| Nov 19, 2014 | K141774 | ZOLL X SERIES ZOLL Medical Corporation | MKJ |
| Nov 6, 2014 | K140502 | ZOLL E SERIES ALS ZOLL Medical Corporation | LDD |
| Aug 1, 2014 | K133484 | ZOLL X SERIES Zoll Medical Corp | MKJ |
| Apr 3, 2014 | K132488 | ZOLL CODE WRITER ZOLL Medical Corporation | DXJ |
| Dec 17, 2013 | K131919 | ZOLL EPCR IOS ZOLL Medical Corporation | DXJ |
| Dec 13, 2012 | K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER ZOLL Medical Corporation | MKJ |
| Nov 20, 2012 | K121865 | ZOLL RESCUENET 12-LEAD ZOLL Medical Corporation | MSX |
| Jun 21, 2012 | K121367 | ZOLL PROPAQ XM ZOLL Medical Corporation | MHX |
| May 10, 2012 | K112660 | POCKETCPR Zoll Medical Corp | LIX |
| May 13, 2011 | K110978 | ONESTEP PEDIATRIC MFE'S ZOLL Medical Corporation | MKJ |
| May 13, 2011 | K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR ZOLL Medical Corporation | DXJ |
| Apr 13, 2011 | K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE ZOLL Medical Corporation | MKJ |
| Mar 25, 2011 | K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE ZOLL Medical Corporation | MKJ |
| Sep 23, 2010 | K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE ZOLL Medical Corporation | MKJ |
| Sep 23, 2009 | K090989 | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES Zoll Medical Corp | MKJ |
| May 20, 2009 | K090736 | POWER INFUSER, MODEL M100B-3A ZOLL Medical Corporation | FRN |
| Dec 9, 2008 | K081828 | ZOLL R SERIES BLS DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Dec 4, 2008 | K080903 | ZOLL E SERIES WITH INTIBATION ASSIST OPTION ZOLL Medical Corporation | MKJ |
| Sep 18, 2008 | K081574 | ZOLL R SERIES ZOLL Medical Corporation | LDD |
| Nov 6, 2007 | K072430 | ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE ZOLL Medical Corporation | MKJ |
| Feb 28, 2007 | K062537 | ZOLL M SERIES WITH REAL CPR HELP ZOLL Medical Corporation | MKJ |
| Dec 13, 2006 | K062177 | ZOLL E SERIES WITH REAL CPR HELP ZOLL Medical Corporation | MKJ |
| Aug 17, 2006 | K060559 | ZOLL R SERIES DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Jun 24, 2005 | K051475 | ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL Medical Corporation | MKJ |
| May 13, 2005 | K051076 | ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES ZOLL Medical Corporation | MKJ |
| Apr 7, 2005 | K042007 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corp | MKJ |
| Feb 4, 2005 | K041892 | ZOLL AED PRO EXTERNAL DEFIBRILLATOR ZOLL Medical Corporation | MKJ |
| Oct 26, 2004 | K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE Zoll Medical Corp | LDD |
| Oct 5, 2004 | K042417 | ZOLL M SERIES ETC02 LOFLO OPTION Zoll Medical Corp | MKJ |
| May 21, 2004 | K033474 | ZOLL AED PLUS Zoll Medical Corp | MKJ |
| Nov 13, 2003 | K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES Zoll Medical Corp | LDD |
| Nov 5, 2003 | K032439 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp | MKJ |
| Oct 31, 2003 | K032363 | ZOLL M SERIES NIBP OPTION Zoll Medical Corp | DXN |
| Apr 11, 2002 | K011541 | ZOLL PAD WITH CPR AID Zoll Medical Corp | MKJ |
| Mar 25, 2002 | K011388 | ZOLL PAD Zoll Medical Corp | MKJ |
| Jul 31, 2001 | K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION Zoll Medical Corp | DSK |
| Feb 28, 2001 | K010257 | ZOLL M SERIES Zoll Medical Corp | MKJ |
| Sep 21, 2000 | K002029 | ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION Zoll Medical Corp | DXN |
| Feb 28, 2000 | K993036 | ZOLL M SERIES ETCO2 OPTION Zoll Medical Corp | MKJ |
| Oct 21, 1999 | K991556 | ZOLL M SERIES 12SL ANALYSIS OPTION Zoll Medical Corp | MKJ |
| Sep 3, 1999 | K990762 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp | MKJ |
| Mar 11, 1999 | K982992 | ZOLL M SERIES SPO2 OPTION Zoll Medical Corp | MKJ |
| Mar 16, 1998 | K972241 | ZOLL REVIVER Zoll Medical Corp | MKJ |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: G5S-80A;
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treat Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: G5S-80C;
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treat Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C;
Software Version: NA
Product Description: The Powerheart G5 automated externa Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO.
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation Brand Name: ZOLL
Product Name: Powerheart G5 AED
Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO.
Software Version: NA
Product Description: The Powerheart G5 automated external defibrillator (AED) Open, Classified |
MKJ | None listed |
| Mar 12, 2025 | ZOLL Medical Corporation 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 Descr Open, Classified |
MKJ | None listed |
| Jul 10, 2024 | Zoll Medical Corporation ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, tha Open, Classified |
MKJ | None listed |
| Jun 20, 2024 | ZOLL Medical Corporation 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- Open, Classified |
CBK | K111473 K162832 |
| Jun 12, 2019 | ZOLL Medical Corporation 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, Open, Classified |
MKJ | None listed |
| Aug 4, 2017 | ZOLL Medical Corporation 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 U Terminated |
MKJ | K110742 |
| Jun 30, 2017 | ZOLL Medical Corporation 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 c Terminated |
CBK | K071526 K091238 +2 |
| Mar 31, 2014 | ZOLL Medical Corporation Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. Terminated |
MKJ | K112432 K112761 +1 |
| Sep 17, 2012 | ZOLL Medical Corporation 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 Terminated |
MKJ | K112432 |
| May 25, 2011 | ZOLL Medical Corporation 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 rh Terminated |
MKJ | K042007 |
| Sep 17, 2004 | Zoll Medical Corporation Zoll M Series Automated Defibrillator (AED) Terminated |
MKT | K010257 |
| Jul 10, 2003 | Zoll Medical Corporation Zoll M Series External Defibrillator Terminated |
MKJ | K972241 |
| Feb 6, 2003 | Zoll Medical Corporation Zoll AED Plus Defibrillator (Automatic External Defibrillator) Terminated |
MKJ | K011388 |