LIFEPAK 12 DEFIBRILLATOR/MONITOR— 510(k) K041459

Name: FDA 510(k) clearance K041459
Creator: U.S. Food and Drug Administration
Published: 2004-07-01

Substantially Equivalent

Medtronic Emergency Response Systems, Inc.

FDA 510(k) clearance K041459 for LIFEPAK 12 DEFIBRILLATOR/MONITOR, Substantially Equivalent on 2004-07-01. Applicant: Medtronic Emergency Response Systems, Inc.. Device class: 3.

Clearance details

Applicant: Medtronic Emergency Response Systems, Inc.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2004-06-02
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

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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

More clearances from Medtronic Emergency Response Systems, Inc.

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K063510 — LIFEPAK 12 DEFIBRILLATOR/MONITOR2007-01-26
K063119 — LIFEPAK 20 DEFIBRILLATOR/ MONITOR2006-12-22
K052057 — LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR2006-02-17
K052854 — LIFENET EXCHANGE SYSTEM2006-01-20
K042404 — LIFEPAK, MODEL 10002005-12-22

Adverse events under product code MKJ

product code MKJ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.