đź“‹ FDA Reference
philips heartstart fr2 automated external defibrillator models m3860a m3861a m3840a m3841a
Philips Medical Systems
Summary: The Philips HeartStart FR2 is an automated external defibrillator used to treat sudden cardiac arrest. It is designed for use by lay responders in public settings.
FDA Clearance Information
Pathway
510K
Number
K051632 ↗
Decision Date
October 5, 2005
Product Code
MKJ
Device Class
Class 3
Evidence
419 studies
The Philips HeartStart FR2 AED was cleared through the FDA 510(k) pathway on October 5, 2005. It is manufactured by Philips Medical Systems and classified as a Class III device.
What It Is
The Philips HeartStart FR2 is an automated external defibrillator (AED) designed to deliver a controlled electric shock to the heart in cases of sudden cardiac arrest, particularly when ventricular fibrillation is present. The device provides voice prompts to guide users through the defibrillation process, making it accessible to non-medical personnel. It is portable, battery-operated, and intended for use in public places.
Clinical Applications
The HeartStart FR2 AED is commonly used in emergency situations where a person has collapsed due to sudden cardiac arrest. It is suitable for use in various settings such as airports, schools, sports arenas, and other public venues. The device is particularly valuable in pre-hospital settings where immediate medical intervention is critical. It is used by first responders, including police, firefighters, and trained laypersons.
Indications for Use
The FDA indications for the HeartStart FR2 AED focus on its use for individuals experiencing sudden cardiac arrest, especially when ventricular fibrillation is detected. It is intended for use by trained responders to increase the chances of survival before professional medical help arrives.
Practical Considerations
The HeartStart FR2 AED is designed to be user-friendly, with clear voice instructions and visual prompts. It is compatible with adult and pediatric electrode pads, which should be selected based on the patient's age and size. Regular maintenance, including battery checks and pad replacements, is essential to ensure readiness.
Related Literature
The linked study titled 'Defibrillators' from 2004 highlights the critical role of rapid defibrillation in improving survival rates for out-of-hospital cardiac arrests with ventricular fibrillation. The study emphasizes the importance of training laypersons to use AEDs, which can significantly increase survival odds. However, the study's limitations include its focus on general AED use rather than specific device performance.
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 FR2 AED used for?
It is used to deliver an electric shock to the heart in cases of sudden cardiac arrest, particularly when ventricular fibrillation is present.
What specialties typically use this device?
Emergency medicine, cardiology, and first responders such as police, firefighters, and trained laypersons use this device.
What are the FDA-cleared indications?
The device is indicated for use in individuals experiencing sudden cardiac arrest, especially with ventricular fibrillation, to increase survival chances before medical help arrives.
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.