510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 242 of 3528

510(k) clearances, page 242 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222680	DeltaScan Monitor	Prolira B.V.	NCG	Class II	2023-02-02
K222671	DeltaScan Patch	Prolira B.V.	GXY	Class II	2023-02-02
K222422	Polaris Valve Electronic Reading Instrument	Sophysa	JXG	Class II	2023-02-02
K222211	Implant Direct Dental Implant Systems Portfolio - MR Conditional	Implant Direct Sybron Manufacturing LLC	DZE	Class II	2023-02-02
K221781	Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH	Guangdong Optomedic Technologies, Inc.	GCJ	Class II	2023-02-02
K221515	StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring	Boston Scientific Corporation	FGB	Class II	2023-02-02
K221356	Wee Bell	Wee Medical	HFX	Class II	2023-02-02
K220126	Geonic Nasal Aspirator, Geonic Nasal Cleaner	Geon Corporation	BTA	Class II	2023-02-02
K213545	Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869	Steelco S.p.A.	FLE	Class II	2023-02-02
K210751	S.E.A.L. Hemostatic Wound Spray	BC3 Technologies	QSY	Unclassified	2023-02-02
K230020	BriefCase	Aidoc Medical Ltd.	QFM	Class II	2023-02-01
K223396	Rapid RV/LV	Ischemaview, Inc.	QIH	Class II	2023-02-01
K223330	Certas Plus Programmable Valves	Integra LifeSciences Production Corporation	JXG	Class II	2023-02-01
K222970	LVivo IQS	Dia Imaging Analysis, Ltd.	QIH	Class II	2023-02-01
K222863	Garment Electrodes	Tone-a-Matic International, Inc.	GXY	Class II	2023-02-01
K222751	LED Light Therapy Device, KN-7000L	Xuzhou Kernel Medical Equipment Co Ltd	GEX	Class II	2023-02-01
K221943	EmbedMed	3D Lifeprints UK, Ltd.	PBF	Class II	2023-02-01
K221168	Tinnitogram Signal Generator	Goldenear Company, Inc.	KLW	Class II	2023-02-01
K213480	31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil	Rapid Biomedical GmbH	MOS	Class II	2023-02-01
DEN220014	RefleXion Medical Radiotherapy System (RMRS)	Reflexion Medical, Inc.	QVA	Class II	2023-02-01
K223351	Naviswiss Knee	Naviswiss AG	OLO	Class II	2023-01-31
K223117	V-Sperm Wash	VITROMED GmbH	MQL	Class II	2023-01-31
K221200	XBody Go USA, XBody Pro USA	Xbody Hungary Kft.	NGX	Class II	2023-01-31
K223348	My3D® Personalized Pelvic Reconstruction	Onkos Surgical, Inc.	LPH	Class II	2023-01-30
K222567	Playground For All Love Sesh	Playground for All	NUC	Class II	2023-01-30
K221532	PHMB Wound Dressing	Winner Medical Co., Ltd.	FRO	Unclassified	2023-01-30
K210112	XChange Device, XChange System	Pneuma Therapeutics, Inc.	CCK	Class II	2023-01-30
K212684	BrainView QEEG Software	Medeia Inc	OLU	Class II	2023-01-28
K223927	360Cas	Kico Knee Innovation Company	OLO	Class II	2023-01-27
K223903	Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)	Semperit Investments Asia Pte, Ltd.	LZA	Class I	2023-01-27
K223546	14Hq721g-B	LG Electronics.Inc	MQB	Class II	2023-01-27
K223254	C2 Xplore	Inomed Medizintechnik GmbH	ETN	Class II	2023-01-27
K223090	GEM Premier ChemSTAT	Instrumentation Laboratory Co.	CGA	Class II	2023-01-27
K223016	BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit	BD	PSZ	Class II	2023-01-27
K222901	EVA15 insufflator	Palliare	HIF	Class II	2023-01-27
K222835	Prophecy Preoperative Navigation Alignment System	Wrightmedicaltechnologyinc	HSN	Class II	2023-01-27
K222664	Sim&Size	Sim&cure	PZO	Class II	2023-01-27
K221868	QOCA image Smart CXR Image Processing System	Quanta Computer Inc	QFM	Class II	2023-01-27
K221551	FUJIFILM Endoscope Model EI-740D/S	Fujifilm Corporaton	FDS	Class II	2023-01-27
K221338	F&P Airvo 3	Fisher & Paykel Healthcare, Inc.	QAV	Class II	2023-01-27
K221306	SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories	Gyrus ACMI, Inc.	GEX	Class II	2023-01-27
K220803	VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin	bioMerieux, Inc.	LON	Class II	2023-01-27
K213059	Tibia and Fibula System	Auxein medical Private Limited	HRS	Class II	2023-01-27
K211559	EasyStat 300	Medica Corp.	CHL	Class II	2023-01-27
K210166	Omnispec ED1000	Medispec, Ltd.	ISA	Class I	2023-01-27
K203833	Tacrolimus Assay Kit	Shanghai Genext Medical Technology Co., Ltd.	MLM	Class II	2023-01-27
K223588	PALLAS Premium	Laseroptek	GEX	Class II	2023-01-26
K223415	Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Mah Sing Healthcare Sdn Bhd	LZA	Class I	2023-01-26
K222779	Revogene	Meridian Bioscience Inc	OOI	Class II	2023-01-26
K222589	Flexible Suturing System with Anchors (FSSA)	Integrity Orthopaedics, Inc.	MBI	Class II	2023-01-26