ONESTEP ADULT MULTI-FUNCTION ELECTRODE— 510(k) K110742

Clearance details

Applicant

ZOLL Medical Corporation

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2011-03-17

Decision date

2011-04-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Pawtucket, RI, 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

• K233486 — 731 Series Ventilator2024-12-13
• K202375 — ZOLL Propaq M2021-03-09
• K180482 — ZOLL Propaq M2018-11-30
• K172653 — Power Infuser2018-07-18
• K162832 — 731 Series Ventilators2017-08-02

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-0977-2018 — 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 Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.Class II·Terminated·ZOLL Medical Corporation·20170804

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110742.