Class I (Low Risk)

General controls only (e.g., labeling, GMP); most exempt from premarket review (~47% of devices).

Medical Disposables: Bandages, tongue depressors, exam gloves, manual stethoscopes.

Class II (Moderate Risk)

General + special controls (e.g., performance standards, post-market surveillance); usually requires 510(k).

Powered wheelchairs, infusion pumps, pregnancy test kits, surgical drapes.

Class III (High Risk)

General controls + premarket approval (PMA) with clinical data; supports/sustains life (~10% of devices).

Pacemakers, artificial heart valves, implantable defibrillators, breast implants.

Anesthesiology

Devices for anesthesia delivery, monitoring, and respiratory support.

Anesthesia machines, ventilators, endotracheal tubes.

Cardiovascular

Tools for heart/vascular diagnosis, treatment, and monitoring.

Stents, ECG monitors, pacemakers, heart valves.

Clinical Chemistry & Toxicology

Lab devices for chemical analysis of body fluids.

Blood glucose meters, electrolyte analyzers, toxicology kits.

Ear, Nose, Throat (ENT)

Instruments for ENT diagnosis and surgery.

Hearing aids, otoscopes, sinus endoscopes.

Gastroenterology & Urology

Devices for GI tract and urinary system management.

Endoscopes, catheters, dialysis machines.

General & Plastic Surgery

Tools for surgical procedures and wound care.

Scalpels, sutures, breast implants, laser surgery devices.

Hematology & Pathology

Equipment for blood/tissue analysis.

Blood cell counters, microscopes, biopsy needles.

Immunology & Microbiology

Devices for immune response and infection testing.

ELISA readers, PCR machines, antigen test kits.

Neurology

Tools for brain/nerve disorders.

EEG machines, deep brain stimulators, shunts.

Obstetrics & Gynecology

Devices for reproductive health.

Fetal monitors, IUDs, ultrasound probes.

Ophthalmic

Instruments for eye care.

Contact lenses, phacoemulsifiers, intraocular lenses.

Orthopedic

Supports and implants for musculoskeletal issues.

Hip/knee implants, bone drills, braces.

Physical Medicine

Aids for rehabilitation and mobility.

Wheelchairs, TENS units, CPAP machines.

Radiology

Imaging and radiation therapy devices.

X-ray machines, MRI scanners, CT systems.

Toxicology

Detection of poisons/substances.

Drug test strips, mass spectrometers.

General Hospital & Personal Use

Broad-use items for patient care.

Hospital beds, thermometers, IV poles.

Diagnostic Equipment

Tools for assessing health conditions (often Class I/II).

X-ray machines, ultrasounds, MRI/CT scanners, ECGs, endoscopes.

Therapeutic/Treatment Equipment

Devices for active intervention or symptom relief.

Infusion pumps, radiotherapy machines, defibrillators, dialysis units.

Monitoring Equipment

Continuous or intermittent patient surveillance.

Pulse oximeters, ventilators, blood pressure monitors, Holter monitors.

Surgical & Procedural Instruments

Reusable/disposable tools for procedures (sterilizable).

Scalpels, forceps, endoscopes, laparoscopic tools, implants.

Durable Medical Equipment (DME)

Long-term, home-use items (often Class I; Medicare-reimbursable).

Wheelchairs, oxygen concentrators, hospital beds, walkers.

Laboratory & In Vitro Diagnostic (IVD) Equipment

For sample analysis (IVDs often Class II).

Centrifuges, microscopes, PCR analyzers, blood analyzers.

Assistive & Rehabilitation Devices

Aids for daily living and recovery.

Prosthetics, hearing aids, mobility scooters, orthotics.

Storage, Transport & Auxiliary Equipment

Support for logistics and hygiene.

Sterilizers, medical refrigerators, patient stretchers, oxygen supply systems.

Instruments for DNA amplification, gene expression analysis, and qPCR in molecular biology.

Separate samples by density for cell isolation, protein purification, and nucleic acid prep.

Visualize cells, tissues, and molecules; used in cell biology, pathology, and cryo-EM.

Measure nucleic acid/protein concentration, purity, and fluorescence for quantification.

Analyze proteins, metabolites, and biomolecules for proteomics and metabolomics.

Separate and purify biomolecules like proteins and nucleic acids; essential for biopharma.

Analyze and sort cells based on size, granularity, and markers for immunology and cancer research.

Maintain controlled environments for cell culture, bacterial growth, and hybridization.

Automate pipetting, dispensing, and workflows for high-throughput screening.

Separate DNA/proteins by size; used in Western blots and gel electrophoresis.