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ZOLL Manufacturing Corporation: FDA-registered device maker in Pittsburgh, PA, United States, 3 510(k) clearances and 1 PMA approval

Name: ZOLL Manufacturing Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ZOLL Manufacturing Corporation is registered with the FDA (registration 3008642652) in Pittsburgh, PA, United States. It lists 5 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated December 19, 2019. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008642652
Address: 121 Gamma Dr, Pittsburgh, PA, United States, 15238
Owner or operator: ZOLL Manufacturing Corporation (9045611)
Roles: Manufacturer
First device listed: November 8, 2007
Registered through: 2026
Brand names listed: LifeVest Wearable Defibrillator, ZOLL Arrhythmia Management System, ZOLL ECG Analysis Software, uCor Heart Failure and Arrhythmia Management System

Devices it lists

Device	Product code	Class	Role	Source
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Manufacturer	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 19, 2019	K190939	ZOLL Arrhythmia Management Sysyem	MHX	Substantially Equivalent	Zoll Manufacturing Corporation	accessdata.fda.gov
January 28, 2019	K182093	ZOLL ECG Analysis Software	DPS	Substantially Equivalent	Zoll Manufacturing Corporation	accessdata.fda.gov
May 11, 2018	K172510	µCor Heart Failure and Arrhythmia Management System	MHX	Substantially Equivalent	Zoll Manufacturing Corporation	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 18, 2001	P010030	WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST	MVK	198	October 6, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 12, 2017	78926	Class II	Terminated	LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refu	Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure	accessdata.fda.gov
September 24, 2010	56957	Not yet classified	Terminated	Model 4000 Monitor component of the LifeVest Wearable Defibrillator	The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.	accessdata.fda.gov
October 21, 2008	50119	Not yet classified	Terminated	Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are no	The charging circuit will not shut down properly.	accessdata.fda.gov
September 14, 2007	44942	Not yet classified	Terminated	Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).	Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.	accessdata.fda.gov
April 27, 2007	37869	Not yet classified	Terminated	Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.	The electrodes do not properly release conductive gel	accessdata.fda.gov
January 10, 2003	25387	Not yet classified	Terminated	Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.	Wires may break or pull out, causing device to malfunction	accessdata.fda.gov

Compare with other makers

Updated October 6, 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.