LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM— 510(k) K010918

Name: FDA 510(k) clearance K010918
Creator: U.S. Food and Drug Administration
Published: 2001-08-23

Substantially Equivalent - Subject to Tracking Reg.

Medtronic Physio-Control Corp.

FDA 510(k) clearance K010918 for LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 2001-08-23. Applicant: Medtronic Physio-Control Corp.. Device class: 3.

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: 2001-03-27
Decision date: 2001-08-23
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

view all

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 Physio-Control Corp.

view all

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
K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR2001-12-03

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.