LIFEPAK 12, 20, 500, CR PLUS— 510(k) K033275

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

2003-10-10

Decision date

2003-11-06

Decision

Substantially Equivalent

Clearance type

Special

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
• K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODES2002-12-13
• K012274 — MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER2002-02-05
• K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR2001-12-03
• 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-2100-2016 — LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.Class II·Terminated·Physio-Control, Inc.·20160525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033275.