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 258 of 3528

510(k) clearances, page 258 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221521	Disposable Safety Lancet	Sterilance Medical (Suzhou) Inc.	FMK	Class II	2022-10-28
K221435	Supertilt Plus (Stp)	Power Plus Mobility Inc	IOR	Class I	2022-10-28
K220869	Vapotherm Aerosol Adapter AAA-2	Vapotherm Inc.	CAF	Class II	2022-10-28
K220305	Syntheon LAA Exclusion System, Syntheon LAA Selection Guide	Syntheon, LLC	PZX	Class II	2022-10-28
K214109	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	Kontour (Xi'an) Medical Technology Co., Ltd.	GXN	Class II	2022-10-28
K212473	Welch Allyn Connex Central Station	Welch Allyn Inc	MWI	Class II	2022-10-28
K211060	Disposable Surgical Gown Rk-3011C	Xiantao Rhycom Non-Woven Products Co., Ltd.	FYA	Class II	2022-10-28
K222966	Cirq Arm System (2.0);Alignment System Spine	Brainlab, Inc.	OLO	Class II	2022-10-27
K222952	2008T BlueStar Hemodailysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2022-10-27
K222678	Mobility+ Enteral Feeding System	Rockfield Medical	PIF	Class II	2022-10-27
K222601	FilmArray Pneumonia Panel plus	BioFire Diagnostics, LLC	QDS	Class II	2022-10-27
K222514	S.I.N. Instrument Kits	S.I.N. Implant System Ltda	KCT	Class II	2022-10-27
K222505	CurvaFix IM System	Curvafix, Inc.	HWC	Class II	2022-10-27
K222348	Jr Medic	JR Engineering and Medical Technologies (M) Sdn Bhd	LYY	Class I	2022-10-27
K222288	DESS Dental Smart Solutions	Terrats Medical, S.L.	NHA	Class II	2022-10-27
K222282	HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System	Hospital Equipment Manufacturing Company	HRS	Class II	2022-10-27
K222231	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	DZE	Class II	2022-10-27
K221489	Artemis Proximal Femoral Nail System	Glw, Inc.	HSB	Class II	2022-10-27
K221420	AlphaID™ At Home Genetic Health Risk Service	Progenika Biopharma S.A., A Grifols Company	PTA	Class II	2022-10-27
K221322	CUSTMBITE Snoring System	Dental Choice Holdings LLC	LRK	Class II	2022-10-27
K220949	Architect CMV IgG	Abbott Medical	LFZ	Class II	2022-10-27
K220880	Arthrex BioSuture	Arthrex GmbH	GAT	Class II	2022-10-27
K220332	uMR Omega with uWS-MR-MRS	Shanghai United Imaging Healthcare Co., Ltd.	LNH	Class II	2022-10-27
K212745	ORAcollect®•Dx	DNA Genotek Inc.	OYJ	Class II	2022-10-27
K223235	Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)	PT. Sintong Unigolden Glove	LZA	Class I	2022-10-26
K223065	Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices	Adcura, Inc.	MAX	Class II	2022-10-26
K223060	DigiX FDX	Allengers Medical Systems Limited	KPR	Class II	2022-10-26
K223058	EzRay Air 2 Wall (Model: VEX-S350W)	Vatech Co., Ltd.	EHD	Class II	2022-10-26
K222807	TEMA Elbow system - Line extension	Lima Corporate S.p.A.	JDB	Class II	2022-10-26
K222631	Vassallo Gt Ext	Filmecc Co., Ltd.	DQX	Class II	2022-10-26
K222498	Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)	Humanwell Healthcare Group Medical Supplies Co., Ltd.	LZA	Class I	2022-10-26
K222366	EsoCheck Cell Collection Device	Lucid Diagnostics, Inc.	EOX	Class II	2022-10-26
K222281	Intracept Intraosseous Nerve Ablation System	Relievant Medsystems	GXI	Class II	2022-10-26
K222269	DESS Dental Smart Solutions	Terrats Medical, S.L.	NHA	Class II	2022-10-26
K222047	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)	Elekta Solutions AB	IWB	Class II	2022-10-26
K222032	NEUROMARK System	Neurent Medical Inc.	GEI	Class II	2022-10-26
K221885	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports	23AndMe, Inc.	QDJ	Class II	2022-10-26
K221374	Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)	Hebei Titans Hongsen Medical Technology Co.,Ltd	LYY	Class I	2022-10-26
K221218	Silverlon Wound Contact, Burn Contact Dressings	Argentum Medical, LLC	FRO	Unclassified	2022-10-26
K220823	Preat Abutments	PREAT Corporation	NHA	Class II	2022-10-26
K220132	FIREFLY® Cervical Navigation Guide	Mighty Oak Medical	QSD	Class II	2022-10-26
K213690	Eclipse Blood Collection Set	Eclipse Medcorp, LLC	JKA	Class II	2022-10-26
K222968	Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2022-10-25
K222470	3Dicom MD	Singular Health Pty Ltd	LLZ	Class II	2022-10-25
K222415	Rexious Spinal Fixation System	Dio Medical Co., Ltd.	NKB	Class II	2022-10-25
K222365	Leltek Ultrasound Imaging System (Model: LU700 Series)	Leltek Inc.	IYN	Class II	2022-10-25
K222303	Unistik® Pro	Owen Mumford Limited	FMK	Class II	2022-10-25
K222070	EndoNaut	Therenva SAS	OWB	Class II	2022-10-25
K221169	JR MEDIC Nitrile Examination Gloves Powder Free- Black	JR Engineering and Medical Technologies (M) Sdn Bhd	LZA	Class I	2022-10-25
K220565	Hudson RCI Triflo II Incentive Deep Breathing Exerciser	MEDLINE INDUSTRIES, LP - Northfield	BWF	Class II	2022-10-25