Atlas FDA

SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

FDA 510(k) clearance K013896 · decided 2002-06-19

Clearance details

K-number
K013896
Device name
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
Applicant
Defibtech, LLC
Decision
Substantially Equivalent - Subject to Tracking Reg.
Date received
2001-11-23
Decision date
2002-06-19
Days to decision
208 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Guilford, CT, 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.

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LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
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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
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 recall (Z-2064-2011)Defibtech, LLC2011-05-16
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillat recall (Z-0077-2011)Defibtech, LLC2010-10-18
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery P recall (Z-1781-2010)Defibtech LLC2010-06-10
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manu recall (Z-1782-2010)Defibtech LLC2010-06-10
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand - recall (Z-0580-2007)Defibtech, LLC2007-03-08

PMA approvals by this applicant

RecordFirmDate
Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032/S013)Defibtech, LLC2025-07-03
Defibtech Lifeline, Defibtech Lifeline AUTO (P160032/S012)Defibtech, LLC2024-12-05
Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E (P160032/S011)Defibtech, LLC2024-09-06
Defibtech Automated External Defibrillator (AED) Systems (P160032/S010)Defibtech, LLC2021-09-10
Defibtech's Automated External Defibrillator (AED) System (P160032/S005)Defibtech, LLC2021-06-10
Defibtech Automated External Defibrillator (AED) Systems (P160032/S002)Defibtech, LLC2021-02-25
Defibtech Automated External Defibrillator (AED) Systems (P160032/S003)Defibtech, LLC2020-11-18
Defibtech Automated External Defibrillator (AED) Systems (P160032/S009)Defibtech, LLC2020-10-23