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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 896 of 3530

510(k) clearances, page 896 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120763	Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls	Lin-Zhi International Inc	DJG	Class II	2012-06-01
K120679	Synapse 3D Nodule Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2012-06-01
K120672	Kd-936 Fully Automatic Wireless Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2012-06-01
K120638	Vantage Titan	Toshibamedical Systems Corporation	LNH	Class II	2012-06-01
K120542	Cardinal Health Durablue Sterilization Wrap	Medtronic, Inc.	FRG	Class II	2012-06-01
K120346	Cleaner Rotational Thrombectomy System	Rex Medical LP	MCW	Class II	2012-06-01
K113846	Borrelia Burgdorferi Igm Blot Test	Gold Standard Diagnostics, LLC	LSR	Class II	2012-06-01
K113438	Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	JMO	Class I	2012-06-01
K112937	Mrsa/sa Elite Mgb	Elitech	NQX	Class II	2012-06-01
K112900	Smr Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads	Lima Corporate S.p.A.	HSD	Class II	2012-06-01
K112580	Collagen Wound Dressing	Dalim Tissen Co., Ltd.	KGN	Unclassified	2012-06-01
K111798	Sternic Implant 4.2Mm Rn, 1.8Mm, 8.0Mm / 4.1Mm Rn, 1.8Mm, 10.Mm / 4.1 Mm Rn, 1.8Mm, 12.0Mm / 4.1Mm Rn, 1.8Mm, 14.0Mm ...	Sterngold Dental LLC	DZE	Class II	2012-06-01
K121466	Guidemia	Guidemia Technologies, LLC	LLZ	Class II	2012-05-31
K121322	Closer to Nature	Mayborn Group Limited	HGX	Class II	2012-05-31
K121307	Optetrak Logic Cr Tibial Insert, Size 0 Optetrak Logic Cr Tibial Insert, Size 6 Optetrak Logic Cr Femoral Component, Siz	Exactech, Inc.	JWH	Class II	2012-05-31
K121023	Spectrum V.0	Intrinsic Medical Imaging	LLZ	Class II	2012-05-31
K120944	Kendall Scd 700 Sequential Compression Controller	Medtronic, Inc.	JOW	Class II	2012-05-31
K120620	Clean and Boost	Apex Dental Materials, Inc.	KLE	Class II	2012-05-31
K120441	Getinge 700Hc-E Series Steam Sterilizer	Getinge Sourcing, LLC	FLE	Class II	2012-05-31
K120033	Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac via Therapy Unit	KCI USA, Inc.	OMP	Class II	2012-05-31
K111382	Celver	Cellulose Concepts, LLC	FRO	Unclassified	2012-05-31
K110734	Nci Spatula	Fischer Surgical Inc.	OTZ	Class I	2012-05-31
K121340	Somnodent G2	Somnomed Inc.	LRK	Class II	2012-05-30
K121283	Bd Emerald Saf-T Single Use, Hypodermic	Becton Dickinson & Co	FMF	Class II	2012-05-30
K120882	Site Rite Prevue Ultrasound System and Pinpoint Needle Guide	Bard Access Systems, Inc.	IYO	Class II	2012-05-30
K120829	Stainless Steel Spinal System	Theken Companies LLC	NKB	Class II	2012-05-30
K120574	Hamilton-C1	Hamilton Medical AG	CBK	Class II	2012-05-30
K120543	Tandemheart Femoral Arterial Cannula Set	Cardiacassist, Inc.	DWF	Class II	2012-05-30
K120412	3M Spoton Temperature Monitoring System	Arizant Healthcare, Inc.	FLL	Class II	2012-05-30
K120395	Neria Multi Subcutaneous Infusion Set	Unomedical Devices S.A de C.V	FPA	Class II	2012-05-30
K120271	Artisan Space Maintenance System	Medtronic Sofamor Danek USA Inc	JEY	Class II	2012-05-30
K120170	Procare Plus Vitrectomy System	Visioncare Devices, Inc.	HQE	Class II	2012-05-30
K120084	Endoscopic Retrieval Device	United States Endoscopy Group, Inc.	OCZ	Class II	2012-05-30
K113739	Simplant Immediate Smile Dental Care System	Materialise Dental NV	LLZ	Class II	2012-05-30
K113402	Solohealth Station	Solohealth, Inc.	DXN	Class II	2012-05-30
K112859	Erapid Nebulizer System	Pari Respiratory Equipment, Inc.	CAF	Class II	2012-05-30
K112621	Wis1000	Foreseeson Custom Displays, Inc.	GCJ	Class II	2012-05-30
K111956	Kronus Voltage Gated Calcium Channel (Vgcc) Antibody Ria Assay Kit	Kronus Market Development Associates, Inc.	PAF	Class II	2012-05-30
K121427	Unimed Temperature Probe	Unimed Medical Supplies Inc	FLL	Class II	2012-05-29
K120360	Ortho Solutions Trauma Plates for Osteosysnthesis	Ortho Solutions Inc	HRS	Class II	2012-05-29
K113561	Tm Ardis Interbody System Tm Ardis Interbody System Instrumenation	Zimmer Trabecular Metal Technology, Inc.	MAX	Class II	2012-05-29
K111004	Hansen Medical Vascular Catheter Control System and Catheter	Hansen Medical, Inc.	DXX	Class II	2012-05-29
K110472	Si-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	OUR	Class II	2012-05-29
K121380	Weck Vista Optical Bladeless Laparoscopic Access Port	Teleflexmedical, Inc.	GCJ	Class II	2012-05-25
K121039	Copan Mswab Collection, Transport and Preservation System	Copan Flock Technologies	JTW	Class I	2012-05-25
K120964	Upstream Gr Catheter	Upstream Peripheral Technologies Ltd.	DQY	Class II	2012-05-25
K120899	Range Spinal System, Unit Rod	K2M, Inc	MNI	Class II	2012-05-25
K120631	Patient Monitor	Advanced Instruments, LLC	MHX	Class II	2012-05-25
K120612	Medtronic Clear Intravacular Arteriotomy Shunt	Medtronic, Inc.	DWF	Class II	2012-05-25
K120604	K-Laser	Eltech S.R.L	ILY	Class II	2012-05-25