ZOLL PROPAQ MD— 510(k) K112761

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

2011-09-22

Decision date

2012-04-25

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
• K112432 — ZOLL X SERIES2012-03-21

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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112761.