ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004— 510(k) K960676

Clearance details

Applicant

Zoll Medical Corp

Product code

Code DTE

Device class

Class 2

Regulation

21 CFR 870.3600

Advisory panel

Cardiovascular

Date received

1996-02-20

Decision date

1996-06-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Burlington, MA, US

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• K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28

• K133484 — ZOLL X SERIES2014-08-01
• K112660 — POCKETCPR2012-05-10
• K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES2009-09-23
• K042007 — ZOLL E SERIES DEFIBRILLATOR2005-04-07
• K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE2004-10-26

Death

18

Injury

247

Malfunction

4,603

Total

4,868

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-1945-2019 — ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)Class II·Terminated·Bio-Detek, Inc.·20190528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960676.