HEARTSTART MRX, MODEL M3535A— 510(k) K040404

Clearance details

Applicant

Philips Medical Systems, Inc.

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2004-02-17

Decision date

2004-05-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Andover, MA, US

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Death

961

Injury

1,070

Malfunction

90,719

Other

8

Total

92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0278-2018 — Automated External Defibrillator - HeartStart MRx Monitor/DefibrillatorClass II·Terminated·Philips Electronics North America Corporation·20170928
• Z-0348-2018 — ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014Class II·Terminated·Philips Electronics North America Corporation·20170717
• Z-0489-2018 — MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physicianClass I·Terminated·Philips North America, LLC·20170712
• Z-1417-2017 — HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9Class I·Terminated·Philips North America, LLC·20170224
• Z-2842-2016 — HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536AClass II·Terminated·Philips Electronics North America Corporation·20160826
• Z-1612-2016 — HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.Class II·Terminated·Philips Electronics North America Corporation·20160414
• Z-0320-2016 — Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.Class II·Terminated·Philips Electronics North America Corporation·20151014
• Z-0219-2016 — HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physicianClass II·Terminated·Philips Medical Systems, Inc.·20141223
• Z-0204-2016 — Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536AClass II·Terminated·Philips Medical Systems, Inc.·20141119
• Z-0262-2016 — Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physicianClass II·Terminated·Philips Medical Systems, Inc.·20141119
• Z-0273-2016 — ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+Class II·Terminated·Philips Electronics North America Corporation·20141119
• Z-0963-2015 — HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.Class II·Terminated·Philips Medical Systems, Inc.·20141119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040404.