FDA Exempting few devices from 510k Requirements

FDA Exempting few devices from 510k Requirements

Published On - January 31, 2021

QARA FDA 510k

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

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