LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR— 510(k) K052057

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

2005-07-29

Decision date

2006-02-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redmond, WA, 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

• K063510 — LIFEPAK 12 DEFIBRILLATOR/MONITOR2007-01-26
• K063119 — LIFEPAK 20 DEFIBRILLATOR/ MONITOR2006-12-22
• K052854 — LIFENET EXCHANGE SYSTEM2006-01-20
• K042404 — LIFEPAK, MODEL 10002005-12-22
• K041459 — LIFEPAK 12 DEFIBRILLATOR/MONITOR2004-07-01

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-1633-2020 — LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.Class II·Terminated·Physio-Control, Inc.·20200320
• Z-1773-2013 — The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.Class II·Terminated·Physio Control, Inc.·20130612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052057.