LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR— 510(k) K011144

Clearance details

Applicant

Medtronic Physio-Control Corp.

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2001-04-16

Decision date

2001-12-03

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

• K040775 — LIFEPAK 122004-04-23
• K033275 — LIFEPAK 12, 20, 500, CR PLUS2003-11-06
• K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODES2002-12-13
• K012274 — MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER2002-02-05
• K012428 — MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR2001-09-28

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-1082-2013 — The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.Class II·Terminated·Physio Control, Inc.·20130208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011144.