đź“‹ FDA Reference
philips heartstart fr3 automated external defibrillator
Philips Medical Systems
Summary: The Philips HeartStart FR3 is an automated external defibrillator used for emergency treatment of sudden cardiac arrest. It is primarily used by first responders and healthcare professionals in various settings.
FDA Clearance Information
Pathway
510K
Number
K130684 ↗
Decision Date
October 18, 2013
Product Code
MKJ
Device Class
Class 3
Evidence
419 studies
The Philips HeartStart FR3 AED was cleared via the FDA 510k pathway on October 18, 2013. It is manufactured by Philips Medical Systems and classified as a Class 3 device.
What It Is
The Philips HeartStart FR3 is an advanced automated external defibrillator (AED) designed to provide rapid defibrillation in cases of sudden cardiac arrest. It delivers a therapeutic dose of electrical energy to the heart, aiming to restore a normal rhythm. The device is portable, user-friendly, and equipped with features that guide users through the defibrillation process, making it suitable for both professional and layperson use.
Clinical Applications
The HeartStart FR3 is commonly used in emergency medical situations, particularly in pre-hospital settings such as ambulances, public spaces, and clinics. It is vital for first responders, emergency medical technicians (EMTs), and healthcare providers in hospitals and emergency departments. The device is crucial for patients experiencing ventricular fibrillation or pulseless ventricular tachycardia, conditions that require immediate intervention.
Indications for Use
The FDA indications for the HeartStart FR3 include its use in treating sudden cardiac arrest, a condition where the heart unexpectedly stops beating. It is intended for use in patients who are unresponsive and not breathing normally.
Practical Considerations
The HeartStart FR3 is compatible with standard defibrillator pads and can be used on both adults and children with appropriate pediatric pads. It is designed for ease of use with clear voice prompts and a rugged design suitable for various environments.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Philips HeartStart FR3 AED used for?
The Philips HeartStart FR3 AED is used to deliver defibrillation shocks to patients experiencing sudden cardiac arrest to restore a normal heart rhythm.
What specialties typically use this device?
This device is typically used by emergency medical services, cardiologists, and healthcare providers in emergency departments.
What are the FDA-cleared indications?
The FDA-cleared indications include use in patients with sudden cardiac arrest who are unresponsive and not breathing normally.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.