LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR— 510(k) K130454

Clearance details

Applicant

Physio-Control, Inc.

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2013-02-22

Decision date

2013-08-21

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

• K253099 — LIFEPAK 15 AC Power Adapter (41577-000333)2025-10-14
• K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021) +1 more2024-04-30
• K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors2019-06-03
• K142430 — LIFEPAK 15 monitor/defibrillator2014-12-19
• K123597 — TRUECPR COACHING DEVICE2013-04-17

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-0294-2018 — LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.Class I·Terminated·Physio-Control, Inc.·20171204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130454.