Atlas FDA

LIFEPAK 15 monitor/defibrillator

FDA 510(k) clearance K142430 · decided 2014-12-19

Clearance details

K-number
K142430
Device name
LIFEPAK 15 monitor/defibrillator
Applicant
Physio-Control, Inc.
Decision
Substantially Equivalent
Date received
2014-08-29
Decision date
2014-12-19
Days to decision
112 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Redmond, WA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
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BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19
ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441)Bio-Detek, Inc.2014-10-10

Recalls involving this device

RecordFirmDate
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (L recall (Z-0862-2019)Physio-Control Inc2019-02-26
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/def recall (Z-0863-2019)Physio-Control Inc2019-02-26
LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and the recall (Z-1123-2017)Physio-Control, Inc.2017-02-11
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers recall (Z-1993-2016)Physio-Control, Inc.2016-06-15

PMA approvals by this applicant

RecordFirmDate
LIFEPAK® 35 monitor/defibrillator (P160026/S071)Physio-Control, Inc.2026-08-06
LIFEPAK® CR2 Defibrillator (P170018/S025)Physio-Control, Inc.2026-07-30
LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S070)Physio-Control, Inc.2026-07-30
LIFEPAK® 15 monitor/defibrillator (P160026/S068)Physio-Control, Inc.2026-06-25
LIFEPAK® 15 monitor/defibrillator (P160026/S067)Physio-Control, Inc.2026-05-06
LIFEPAK 35 monitor/defibrillator (P160026/S066)Physio-Control, Inc.2026-03-05
LIFEPAK® 35 monitor/defibrillator (P160026/S065)Physio-Control, Inc.2026-02-23
LIFEPAK® 35 Defibrillator/monitor (P160026/S063)Physio-Control, Inc.2025-12-04