Atlas FDA

DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k) clearance K121853 · decided 2012-12-13

Clearance details

K-number
K121853
Device name
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Applicant
Defibtech, LLC
Decision
Substantially Equivalent
Date received
2012-06-25
Decision date
2012-12-13
Days to decision
171 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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Similar devices under this product code

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

RecordFirmDate
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
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

No recalls on record reference this clearance.

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