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 445 of 3528

510(k) clearances, page 445 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191066	CD Horizon™ Astute™ Spinal System	Medtronic Sofamor Danek USA Inc	NQP	Class II	2019-10-03
K190208	Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe	Diversatek Healthcare Inc	FFX	Class II	2019-10-03
K190179	SAHARA Stabilization System	K2M, Inc	OVD	Class II	2019-10-03
K183479	Asthma Monitor AM3	Eresearch Technology	BZG	Class II	2019-10-03
K182143	ALFA GATE Dental Implants System	Alfa Gate - Mazen Ltd.	DZE	Class II	2019-10-03
K192064	LIAISON Vitamin B12	Diasorin Inc.	CDD	Class II	2019-10-02
K191932	Momentum™ Posterior Spinal Fixation System	ulrich medical USA Inc	NKB	Class II	2019-10-02
K191889	NG-Test CARBA 5	NG Biotech	PTJ	Class II	2019-10-02
K191397	OxySoft (olifilcon C) silicone hydrogel soft contact lens	Visco Vision Inc.	LPL	Class II	2019-10-02
K191363	Neocis Planning Software Application (NPSA) for 3rd Party PCs	Neocis Inc.	PLV	Class II	2019-10-02
K190820	Aimanfun Lumea Comfort	Kam Yuen Plastic Products Ltd.	OHT	Class II	2019-10-02
K192453	Diamond-5A/6a/8a	DRGEM Corporation	KPR	Class II	2019-10-01
K192426	Signa Voyager, Signa Voyager Quantum	GE Healthcare (Tianjin) Company Limited	LNH	Class II	2019-10-01
K192416	BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System	Zimmer GmbH	LZO	Class II	2019-10-01
K192303	ExactVu High Resolution Micro-Ultrasound System	Exact Imaging, Inc.	IYN	Class II	2019-10-01
K191958	Aveta System	Meditrina, Inc.	HIH	Class II	2019-10-01
K191610	RTapp	Segana, Inc.	LLZ	Class II	2019-10-01
K191526	Cardioblate CryoFlex Surgical Ablation System	Medtronic, Inc.	OCL	Class II	2019-10-01
K191507	Intellijoint® Navigation System	Intellijoint Surgical Inc.	OLO	Class II	2019-10-01
K183462	Applied Biosystems Bacillus anthracis Detection Kit	Mriglobal	QIF		2019-10-01
K192425	Hair Boom 69, Hair Boom Air, Ulike Hair UpUp	WONTECH Co., Ltd.	OAP	Class II	2019-09-30
K191848	APTUS Wrist Spanning Plates 2.5	Medartis AG	HRS	Class II	2019-09-30
K191844	Fidmi Low Profile Enteral Feeding Device	Fidmi Medical, Ltd.	KGC	Class II	2019-09-30
K191774	SmileAlign Orthodontic Aligner System	3D Global Biotech Inc.	NXC	Class II	2019-09-30
K190048	UF(II) Anatomic abutment	Dio Corporation	NHA	Class II	2019-09-30
K191524	Visalys Tooth Primer	Kettenbach GmbH & Co KG	KLE	Class II	2019-09-29
K192421	EpiFaith Syringe	Flat Medical Co., Ltd.	FMF	Class II	2019-09-27
K192368	CATSmart	Fresenius Kabi AB	CAC	Class II	2019-09-27
K192352	MiniMAX	Medacta International SA	LZO	Class II	2019-09-27
K192129	ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens	Clearlab SG Pte, Ltd.	LPL	Class II	2019-09-27
K192112	FlexBand Plus	International Life Sciences	FTL	Class II	2019-09-27
K192050	ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)	bioMerieux, Inc.	JWY	Class II	2019-09-27
K191747	FUJIFILM Duodenoscope Model ED-580XT	FUJIFILM Corporation	FDT	Class II	2019-09-27
K191521	Radiance 330 Proton Beam Therapy System	Protom International Holding Corporation	LHN	Class II	2019-09-27
K191444	Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir	Medtronic, Inc.	DTZ	Class II	2019-09-27
K191074	Sorrento Bone Graft Substitute	Xenco Medical LLC	MQV	Class II	2019-09-27
K190076	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems	Cepheid	OYX	Class II	2019-09-27
K190059	CEREC Guides	Dentsply Sirona Inc	NDP	Class I	2019-09-27
K190024	Smart-C	Turner Imaging Systems, Inc.	OXO	Class II	2019-09-27
K182722	XLR8 Abdominal Wound Dressing Kit	Genadyne Biotechnologies, Inc.	OMP	Class II	2019-09-27
K181606	Precision Spine Navigation Instrumentation	Precision Spine, Inc.	OLO	Class II	2019-09-27
K180001	Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant	Embla Systems	MNR	Class II	2019-09-27
K192435	NuVasive NuvaLine	Nu Vasive, Incorporated	LLZ	Class II	2019-09-26
K192391	Spectralis HRA+OCT and Variants	Heidelberg Engineering GmbH	OBO	Class II	2019-09-26
K192371	BioZorb SP Marker	Focal Therapeutics	NEU	Class II	2019-09-26
K192364	GXR-Series Diagnostic X-Ray System	DRGEM Corporation	KPR	Class II	2019-09-26
K192195	Sterile Dilator	Galt Medical Corp	DRE	Class II	2019-09-26
K191748	Genesys Spine Sacroiliac Joint Fusion System	Genesys Spine	OUR	Class II	2019-09-26
K191545	Exogenesis Hernia Mesh	Exogenesis Corporation	FTL	Class II	2019-09-26
K191537	eCarbon IBDs	Back 2 Basics Direct, LLC	ODP	Class II	2019-09-26