Few 510K Exempted Class I Device Recently
US FDA planning to exempt certain Medical Devices From FDA 510k Premarket Notification Requirements.
Source: A Notice by the Food and Drug Administration on 01/15/2021
| Device description | Device class | Product code | The section in 21 CFR |
| Powder-free polychloroprene Patient Examination Glove | I | OPC | 880.6250 |
| Patient Examination Glove, Specialty | I | LZC | 880.6250 |
| Radiation Attenuating Medical Glove | I | OPH | 880.6250 |
| Powder-Free Non-Natural Rubber Latex Surgeon”s Gloves | I | OPA | 878.4460 |
| Powder-Free Guayle Rubber Examination Glove | I | OIG | 880.6250 |
| Latex Patient Examination Glove | I | LYY | 880.6250 |
| Vinyl Patient Examination Glove | I | LYZ | 880.6250 |
Few 510K Exempted Class II Device Recently
Class II Devices and Unclassified Devices Proposed Exempt from 510(k) Requirement:
| Device description | Device class | Product code | The section in 21 CFR |
| Ventilator, Continuous, Minimal Ventilatory Support, Home Use | II | NQY | 868.5895 |
| Airway Monitoring System | II | OQU | 868.5730 |
| Impedance Measuring Device Utilizing Oscillation Techniques | II | PNV | 868.1840 |
| Gauge, Pressure, Coronary, Cardiopulmonary Bypass | II | DXS | 870.4310 |
| Valve, Pressure Relief, Cardiopulmonary Bypass | II | MNJ | 870.4400 |
| Oximeter, Tissue Saturation, Reprocessed | II | NMD | 870.2700 |
| Multivariate Vital Signs Index | II | PLB | 870.2300 |
| Electrocardiograph Software for Over-The-Counter Use | II | QDA | 870.2345 |
| Sterilizer, Dry Heat | II | KMH | 880.6870 |
| Check Valve, Retrograde Flow (In-Line) | II | MJF | 880.5440 |
| Intravascular Administration Set, Automated Air Removal System | II | OKL | 880.5445 |
| Neuraxial Administration Set—Intrathecal Delivery | II | PYR | 880.5440 |
| High-Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Liquid | II | PSW | 892.1570 |
| Pediatric/Child Facemask | II | OXZ | 878.4040 |
| Normalizing Quantitative Electroencephalograph Software | II | OLU | 882.1400 |
| Computerized Cognitive Assessment Aid | II | PKQ | 882.1470 |
| Physiological Signal-Based Seizure Monitoring System | II | POS | 882.1580 |
| Computerized Behavioral Therapy Device for Psychiatric Disorders | II | PWE | 882.5801 |
| Monitor, Phonocardiographic, Fetal | II | HFP | 884.2640 |
| Monitor, Cardiac, Fetal | II | KXN | 884.2600 |
| Digital Pathology Display | II | PZZ | 864.3700 |
| Digital Pathology Image Viewing and Management Software | II | QKQ | 864.3700 |
| The system, Imaging, Holography, Acoustic | II | NCS | 892.1550 |
| Lung Computed Tomography System, Computer-Aided Detection | II | OEB | 892.2050 |
| Chest X-Ray Computer-Aided Detection | II | OMJ | 892.2050 |
| Computer-Assisted Diagnostic Software for Lesions Suspicious For Cancer | II | POK | 892.2060 |
| Radiological Computer-Assisted Triage and Notification Software | II | QAS | 892.2080 |
| Radiological Computer-Assisted Detection/Diagnosis Software for Fracture | II | QBS | 892.2090 |
| Radiological Computer-Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer | II | QDQ | 892.2090 |
| Radiological Computer-Assisted Prioritization Software for Lesions | II | QFM | 892.2080 |
| X-ray angiographic Imaging-Based Coronary Vascular Simulation Software Device | II | QHA | 892.1600 |
| Automated Radiological Image Processing Software | II | QIH | 892.2050 |
| Image Acquisition And/Or Optimization Guided by Artificial Intelligence | II | QJU | 892.2100 |
| Apparatus, Vestibular Analysis | Unclassified | LXV | N/A |
| Meter, Peak Flow, Spirometry | II | BZH | 868.1860 |
| Oximeter, Reprocessed | II | NLF | 870.2700 |
| Stethoscope, Electronic | II | DQD | 870.1875 |
| Defoamer, Cardiopulmonary Bypass | II | DTP | 870.4230 |
| Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | II | JOD | 870.4270 |
| Detector, Bubble, Cardiopulmonary Bypass | II | KRL | 870.4205 |
| Cpb Check Valve, Retrograde Flow, In-Line | II | MJJ | 870.4400 |
| Sterilizer, Ethylene-Oxide Gas | II | FLF | 880.6860 |
| Cabinet, Ethylene-Oxide Gas Aerator | II | FLI | 880.6100 |
| Purifier, Air, Ultraviolet, Medical | II | FRA | 880.6500 |
| Cleaner, Air, Medical Recirculating | II | FRF | 880.5045 |
| Controller, Infusion, Intravascular, Electronic | II | LDR | 880.5725 |
| Cleaners, Medical Devices | II | MDZ | 880.6992 |
| Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory for Catheter Position | II | OMF | 880.5970 |
| N95 Respirator with Antimicrobial/Antiviral Agent for Use by The General Public In Public Health Medical Emergencies | II | ORW | 880.6260 |
| Two Or More Sterilant Sterilizers | II | PJJ | 880.6860 |
| High-Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Mist | II | OUJ | 892.1570 |
| Surgical Mask with Antimicrobial/Antiviral Agent | II | OUK | 878.4040 |
| Cerebral Oximeter | II | QEM | 870.2700 |
| Device, Sleep Assessment | II | LEL | 882.5050 |
| Standard Polysomnograph With Electroencephalograph | II | OLV | 882.1400 |
| Source Localization Software for Electroencephalograph or Magnetoencephalography | II | OLX | 882.1400 |
| Automatic Event Detection Software for Polysomnograph With Electroencephalograph | II | OLZ | 882.1400 |
| Amplitude-Integrated Electroencephalograph | II | OMA | 882.1400 |
| Automatic Event Detection Software for Full-Montage Electroencephalograph | II | OMB | 882.1400 |
| Burst Suppression Detection Software for Electroencephalograph | II | ORT | 882.1400 |
| Transducer, Ultrasonic, Obstetric | II | HGL | 884.2960 |
| Tonometer, Ac-Powered | II | HKX | 886.1930 |
| Tonometer, Manual | II | HKY | 886.1930 |
| Automated Digital Image Manual Interpretation Microscope | II | OEO | 864.1860 |
| Analyzer, Medical Image | II | MYN | 892.2070 |
| C-Arm Fluoroscopic X-Ray System | II | RCC | 892.1650 |
| Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection | II | NCP | 870.4210 |
| Respirator, N95, For Use by The General Public In Public Health Medical Emergencies | II | NZJ | 880.6260 |
| Sterilizer Automated Loading System | II | PEC | 880.6880 |
| Infusion Safety Management Software | II | PHC | 880.5725 |
| Gown, Isolation, Surgical | II | FYC | 878.4040 |
| Whole Slide Imaging System | II | PSY | 864.3700 |
| Oxygenator, Long-Term Support Greater Than 6 Hours | II | BZG | 868.1840 |
| Subcutaneous Implanted Apheresis Port | II | QAV | 868.5454 |
| Non-Coring (Huber) Needle | II | BYS | 870.4100 |
| Hood, Surgical* | II | MAJ** | 868.5120 |
| N95 Respirator with Antimicrobial/Antiviral Agent | II | OKC | 880.5970 |
| Monitor, Uterine Contraction, External (For Use in Clinic) | II | PTI | 880.5570 |
| Coil, Magnetic Resonance, Specialty | II | PWH | 880.5440 |
| Oxygenator, Long-Term Support Greater Than 6 Hours | II | FXY | 878.4040 |
| Transmitters and Receivers, Electrocardiograph, Telephone | II | ONT | 878.4040 |
| Extracorporeal System for Long-Term Respiratory/Cardiopulmonary Failure | II | OMC | 882.1400 |
| Implanted Subcutaneous Securement Catheter | II | MOS | 892.1000 |
| Subcutaneous Implanted Apheresis Port | II | QHY | 892.1650 |
