Atlas FDA

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA 510(k) clearance K082937 · decided 2009-03-11

Clearance details

K-number
K082937
Device name
LIFEPAK 15 MONITOR/DEFIBRILLATOR
Applicant
Physio-Control, Inc.
Decision
Substantially Equivalent
Date received
2008-10-01
Decision date
2009-03-11
Days to decision
161 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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Similar devices under this product code

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

RecordFirmDate
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samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
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

Recalls involving this device

RecordFirmDate
Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division recall (Z-1410-2010)Physio Control, Inc.2010-04-21
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor wi recall (Z-2110-2009)Physio Control, Inc.2009-09-18

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