Atlas FDA

HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A

FDA 510(k) clearance K051134 · decided 2005-09-08

Clearance details

K-number
K051134
Device name
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
Applicant
Philips Medical Systems
Decision
Substantially Equivalent
Date received
2005-05-03
Decision date
2005-09-08
Days to decision
128 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
North Attleboro, MA, 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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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

RecordFirmDate
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for us recall (Z-0684-2018)Philips Electronics North America Corporation2018-02-22
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: recall (Z-0489-2018)Philips North America, LLC2018-02-08
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), recall (Z-1417-2017)Philips North America, LLC2017-03-24
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M35 recall (Z-0320-2016)Philips Electronics North America Corporation2015-11-20
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Sy recall (Z-0273-2016)Philips Electronics North America Corporation2015-11-13
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536 recall (Z-0262-2016)Philips Medical Systems, Inc.2015-11-10
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536 recall (Z-0219-2016)Philips Medical Systems, Inc.2015-11-05
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A recall (Z-0204-2016)Philips Medical Systems, Inc.2015-11-03
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M353 recall (Z-0963-2015)Philips Medical Systems, Inc.2015-01-13
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Op recall (Z-1194-2014)Philips Medical Systems, Inc.2014-03-12
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use fo recall (Z-1108-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A recall (Z-1109-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M recall (Z-1110-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M353 recall (Z-1118-2014)Philips Medical Systems, Inc.2014-02-26
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStar recall (Z-1120-2014)Philips Medical Systems, Inc.2014-02-26
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, recall (Z-1090-2014)Philips Medical Systems, Inc.2014-02-25
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M353 recall (Z-0613-2014)Philips Medical Systems, Inc.2013-12-31
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart recall (Z-0593-2014)Philips Medical Systems, Inc.2013-12-27
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx recall (Z-0570-2014)Philips Medical Systems, Inc.2013-12-24
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M recall (Z-1797-2013)Philips Healthcare Inc.2013-07-24
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M353 recall (Z-1189-2013)Philips Healthcare Inc.2013-04-29
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M recall (Z-2347-2012)Philips Healthcare Inc.2012-09-10
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart M recall (Z-1986-2012)Philips Healthcare Inc.2012-07-11
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, an recall (Z-1896-2012)Philips Healthcare Inc.2012-06-27
Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F recall (Z-1609-2011)Philips Healthcare Inc.2011-03-08
HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/de recall (Z-2293-2010)Philips Healthcare Inc.2010-08-27
HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, M recall (Z-1618-2010)Philips Healthcare Inc.2010-05-24
HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips recall (Z-1317-2010)Philips Healthcare Inc.2010-04-09
AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Phili recall (Z-1257-2010)Philips Healthcare Inc.2010-04-08
HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular tachycard recall (Z-1258-2010)Philips Healthcare Inc.2010-04-08
HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardi recall (Z-1259-2010)Philips Healthcare Inc.2010-04-08
DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices includ recall (Z-1260-2010)Philips Healthcare Inc.2010-04-08
Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Modul recall (Z-0562-2010)Philips Healthcare Inc.2009-12-23

PMA approvals by this applicant

RecordFirmDate
HeartStart FRx Defibrillator (861304) (P180028/S019)Philips Medical Systems2026-05-21
HeartStart FRx Defibrillator (P180028/S018)Philips Medical Systems2026-02-02
HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017)Philips Medical Systems2025-09-05
HeartStart FRx Defibrillator (861304) (P180028/S016)Philips Medical Systems2025-06-09
HeartStart FRx Defibrillator (P180028/S015)Philips Medical Systems2025-05-09
HeartStart FRx Defibrillator (861304) (P180028/S014)Philips Medical Systems2024-02-21
HeartStart FRx Defibrillator (P180028/S013)Philips Medical Systems2023-04-03
HeartStart FRx Defibrillator (P180028/S012)Philips Medical Systems2022-03-20