510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ZOLL Manufacturing Corporation

Pittsburgh, PA, US

ZOLL Manufacturing Corporation appears in FDA device records in Pittsburgh, PA. FDA records list 3 510(k) clearances between and , 195 PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
195
Recall records
6
Registered establishments
1

FDA records under these names

2 names

FDA records resolved to ZOLL Manufacturing Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Lifecor Increcall
  • Zoll Lifecor Corporationrecall

510(k) clearance history

FDA records hold 3 510(k) clearances for ZOLL Manufacturing Corporation between 2018 and 2019. The busiest year on record is 2019, with 2. The most recent is 2019, with 2.

Clearances by year, as a table
510(k) clearance decisions for ZOLL Manufacturing Corporation, by decision year
YearClearances
20181
20192
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K190939ZOLL Arrhythmia Management SysyemMHXSubstantially Equivalent
K182093ZOLL ECG Analysis SoftwareDPSSubstantially Equivalent
K172510µCor Heart Failure and Arrhythmia Management SystemMHXSubstantially Equivalent

Registered establishments

FDA registered establishments for ZOLL Manufacturing Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30086426523008642652ZOLL Manufacturing Corporation121 Gamma Dr, Pittsburgh, PA 15238 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0353-2018LifeVest 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 refuse an implantable defibrillator.Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failureClass IITerminated
Z-0625-2011Model 4000 Monitor component of the LifeVest Wearable DefibrillatorThe 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.Terminated
Z-0883-2009Monitor 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 not candidates for or refuse an implantable defibrillator.The charging circuit will not shut down properly.Terminated
Z-0061-2008Battery 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.Terminated
Z-0936-2007Electrode 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 gelTerminated
Z-0578-03Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.Wires may break or pull out, causing device to malfunctionTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain