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 2026-10-15, 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 305 of 3528

510(k) clearances, page 305 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K220053	Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI	FUJIFILM Corporation	KGE	Class II	2022-02-04
K220020	Cryo 7	Zimmer Medizinsysteme GmbH	GEX	Class II	2022-02-04
K214062	Radialis PET Camera	Radialis Inc.	KPS	Class II	2022-02-04
K213938	Revolution Ascend	GE Healthcare Japan Corporation	JAK	Class II	2022-02-04
K213801	Veuron-Brain-pAb2	Heuron Co., Ltd.	LLZ	Class II	2022-02-04
K213777	Stryker Resorbable Fixation System	Stryker Leibinger Micro Implants	JEY	Class II	2022-02-04
K213569	HOLLYWOOD SPECTRA Laser System	Lutronic Corporation	GEX	Class II	2022-02-04
K212849	VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)	bioMerieux, Inc.	LON	Class II	2022-02-04
K212774	VenSure LightGuide	Intersect ENT	LRC	Class I	2022-02-04
K212724	BD Vacutainer UltraTouch Push Button Blood Collection Set	Becton Dickinson & Co	JKA	Class II	2022-02-04
K212721	Genex Bone Graft Substitute	Biocomposites, Ltd.	MQV	Class II	2022-02-04
K212654	Micro C Medical Imaging System, M01	Oxos Medical Inc	IZL	Class II	2022-02-04
K212419	Magnifico Open, Magnifico MSK	Esaote S.p.A.	LNH	Class II	2022-02-04
K212271	smart-sync	Northh Medical GmbH	LNH	Class II	2022-02-04
K211417	F3D-C2 Cervical Stand-Alone System	Corelink, LLC	OVE	Class II	2022-02-04
K210356	Noris Medical Dental Implants System	Noris Medical Ltd.	NHA	Class II	2022-02-04
K220071	Soniquence Reusable Neutral Plate	Soniquence, LLC	GEI	Class II	2022-02-03
K213976	Contour ProtégéAI	MIM Software Inc	QKB	Class II	2022-02-03
K213824	Sonopet iQ Ultrasonic Aspirator System	Stryker Corp.	LFL	Unclassified	2022-02-03
K212382	Ambu® aScope™ Gastro, Ambu® aBox™2	Ambu A/S	FDS	Class II	2022-02-03
K211822	LifePath Remote Patient Monitoring Platform	Elastic Care Incorporated	DRG	Class II	2022-02-03
K210826	Healing Abutment, Cover Screw	Megagen Implant Co., Ltd.	NHA	Class II	2022-02-03
K203335	MectaScrew Extension	Medacta International SA	HWC	Class II	2022-02-03
K213814	Viveve 2.0 System	Viveve, Inc.	GEI	Class II	2022-02-02
K213812	PALACOS MV pro	Heraeus Medical GmbH	LOD	Class II	2022-02-02
K213554	Sentient Manufacturing Laser Fiber	Sentient Manufacturing, LLC	GEX	Class II	2022-02-02
K212079	TeesuVac Breast Biopsy Device Mark 1	Teesuvac ApS	KNW	Class II	2022-02-02
K211603	Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2022-02-02
K211228	Rosso	Quanta System Inc.	GEX	Class II	2022-02-02
K210832	EVOCLEAN CLEANsert Ultrasonic Insert	Ttbio Corporation	ELC	Class II	2022-02-02
K203586	EndoSerter-PL	CorneaGen	OTZ	Class I	2022-02-02
K201403	NATtrol BD MAX Vaginal Panel External Controls	Zeptometrix LLC	PMN	Class II	2022-02-02
K220257	Permadyne	3M Deutschland GmbH	ELW	Class II	2022-02-01
K213830	Home use hair removal device, model: Precise Touch Pro	Iluminage Beauty Co., Limited	OHT	Class II	2022-02-01
K213701	Exeter® X3® RimFit® Cup	Howmedica Osteonics Corp., dba Stryker Orthopaedics	JDI	Class II	2022-02-01
K213565	JETi AIO Peripheral Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2022-02-01
K212611	CO2 Laser Equipment	Beijing Globalipl Development Co., Ltd.	GEX	Class II	2022-02-01
K212410	VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium	Shenzhen VitaVitro Biotech Co.,Ltd.	MQL	Class II	2022-02-01
K211701	X-Guide® Surgical Navigation System	X-NAV Technologies, LLC	QRY	Class II	2022-02-01
K210727	HotDog Warming Mattress + Return Electrode	Augustine Temperature Management, LLC	GEI	Class II	2022-02-01
K203088	Infinity Acute Care System (IACS) Monitoring System	Draeger Medical Systems, Inc.	MHX	Class II	2022-02-01
K220023	8mm Monopolar Curved Scissors	Intuitive Surgical, Inc.	NAY	Class II	2022-01-31
K213908	Skr 3000	Konica Minolta, Inc.	MQB	Class II	2022-01-31
K213401	DIAPLUS Universal	Diadent Group International	KLE	Class II	2022-01-31
K213188	Primary Relief	Dyansys, Inc.	NHI	Class II	2022-01-31
K211628	MIS Precision Chevron Bunion System	Relja Innovations, Inc	HWC	Class II	2022-01-31
K203272	Alltest Pregnancy Rapid Combo Test Cassette	Hangzhou AllTest Biotech Co.,Ltd	JHI	Class II	2022-01-31
K214106	QuikPass Catheter	Traverse Vascular, Inc.	DQY	Class II	2022-01-28
K213523	X-CUBE i8, X-CUBE i9	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2022-01-28
K213325	Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs	Anhui Xinyisheng Medical Technology Co.,Ltd	LZC	Class I	2022-01-28