ZOLL X SERIES— 510(k) K112432

Clearance details

Applicant

Zoll Medical Corporation, World Wide Headquarters

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2011-08-23

Decision date

2012-03-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsmford, MA, US

• K143714 — Powerheart G5 AED2015-05-04
• K150055 — OneStep Pediatric CPR Multi-Function Electrode2015-05-02
• K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
• K142709 — samaritan PAD 450P2015-03-27
• K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

• K133239 — ZOLL E SERIES2015-01-16
• K133269 — ZOLL X SERIES2014-05-22
• K120406 — ZOLL FULLY AUTOMATIC AED PLUS2012-10-26
• K120907 — ZOLL R SERIES2012-09-25
• K112761 — ZOLL PROPAQ MD2012-04-25

Death

961

Injury

1,070

Malfunction

90,719

Other

8

Total

92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1311-2014 — Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.Class II·Terminated·ZOLL Medical Corporation·20140305
• Z-2401-2012 — 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 producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).Class II·Terminated·ZOLL Medical Corporation·20120816

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112432.