FDA Exempting few devices from 510k Requirements

US FDA planning to Exempt Certain Medical Devices From 510 k Premarket Notification Requirements.

Source :A Notice by the Food and Drug Administration on 01/15/2021

Class I Devices Immediately Exempt from 510k Notification Requirements

 

Device description Device class Product code 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

 

 

Class II Devices and Unclassified Devices Proposed Exempt from 510(k) Requirement:

 

Device description Device class Product code 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
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 Sterilizer 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 Magnetoencephalograph 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

 

*Hood Surgical-Class II, Product code- FXY, Regulation-878.4040

**MAJ, 868.5120 – Catheter, Percutaneous, Intraspinal, Short Term