Atlas FDA

ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE

FDA 510(k) clearance K091561 · decided 2010-09-23

Clearance details

K-number
K091561
Device name
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
Applicant
ZOLL Medical Corporation
Decision
Substantially Equivalent
Date received
2009-05-28
Decision date
2010-09-23
Days to decision
483 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chelsmford, MA, 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
OneStep CPR Complete Electrode (P160022/S049)ZOLL Medical Corporation2025-12-30
AED 3™ (P160015/S025)ZOLL Medical Corporation2025-12-18
X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators (P160022/S046)ZOLL Medical Corporation2025-12-18
ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048)ZOLL Medical Corporation2025-12-09
ZOLL Zenix® Monitor/Defibrillator (P160022/S036)ZOLL Medical Corporation2025-09-29
CPR Uni-padz Electrode (P160022/S047)ZOLL Medical Corporation2025-09-22
CPR-D-padz Electrode (P160015/S026)ZOLL Medical Corporation2025-09-22
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042)ZOLL Medical Corporation2025-08-28