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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1255 of 3531

510(k) clearances, page 1255 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061366	Denlaser 800 Plus	Cao Group, Inc.	GEX	Class II	2006-07-10
K061267	Simulate, Color Change Alginate	Cavex Holland B.V.	ELW	Class II	2006-07-10
K061212	Biotronik Endocardial Pacing Leads	BIOTRONIK AG	DTB	Class III	2006-07-10
K061055	Careo Safety Syringe for U-100 Insulin	Life-Shield Products, Inc.	MEG	Class II	2006-07-10
K060788	Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414	Biosite Incorporated	DIF	Class I	2006-07-10
K053554	Compuflo	Milestone Scientific, Inc.	FRN	Class II	2006-07-10
K061800	Clever Td-1112 Ear/skin/surface Ir Thermometer	Taidoc Technology Corporation	FLL	Class II	2006-07-07
K061654	Trident Constrained Acetabular Insert	Howmedica Osteonics Corp	KWZ	Class II	2006-07-07
K061534	Ziehm Vision Fd Digital Mobile Imaging System	Ziehm Imaging GmbH	OWB	Class II	2006-07-07
K061493	Apex Pins	Howmedica Osteonics Corp	JDW	Class II	2006-07-07
K061329	Infinity Masimo Set Sp02 Pod	Draeger Medical Systems, Inc.	DQA	Class II	2006-07-07
K061321	Zodiac Adjustable Bridges, Models 11-20Xx,11-25Xx,11-30Xx,11-35Xx	Alphatec Spine, Inc.	MNH	Class II	2006-07-07
K061310	Ziehm Vario 3D Digital Mobile Imaging System	Ziehm Imaging GmbH	JAK	Class II	2006-07-07
K060942	Water Purification Components for Hemodialysis	Bob J. Johnson & Associates	FIP	Class II	2006-07-07
K060902	Starclose Introducer Set Model- 1002	Abbott Vascular	DYB	Class II	2006-07-07
K060785	Powder Free Vinyl Synthetic Examination Gloves W/aloe Vera, Green Color	Ever Light Plastic Products Co., Ltd.	LYZ	Class I	2006-07-07
K060363	Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box of 12	Hemcon, Inc.	OLR	Unclassified	2006-07-07
K060289	Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01	Frontline Medical	KNA	Class II	2006-07-07
K053468	Ness L300	Ness-Neuromuscular Electrical Stimulation Systems	GZI	Class II	2006-07-07
K052458	Liv Medica CPR Face Mask	Liv Medica Products Pvt., Ltd.	CBP	Class II	2006-07-07
K061693	Foryou Powered Wheelchair, Model Fc-100	Foryou Technology Co., Ltd.	ITI	Class II	2006-07-06
K061569	Smith & Nephew Competitor Deuce Femoral Components	Smith & Nephew, Inc.	NPJ	Class II	2006-07-06
K061498	Allofix Anchor, 5.0 Mm Anchor	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	JDW	Class II	2006-07-06
K061481	Grengloo	Ormco Corp.	DYH	Class II	2006-07-06
K061382	Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227	Siemens Healthcare Diagnostics Inc.	JZO	Class II	2006-07-06
K061338	Dimension Vista Iga Flex Reagent Cartridge Assay	Siemens Healthcare Diagnostics Inc.	CFN	Class II	2006-07-06
K061181	Achtung Blood Glucose Monitoring System, Model Td-4207	Taidoc Technology Corporation	NBW	Class II	2006-07-06
K061164	Activapin	Bioretec Ltd.	HTY	Class II	2006-07-06
K061150	Sysmex Automated Hematology Analyzer, Xt-Series	Sysmex America, Inc.	GKZ	Class II	2006-07-06
K061139	Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators	Medrad, Inc.	JIT	Class II	2006-07-06
K061137	Advia Ims Cpsa Control	Medrad, Inc.	JJY	Class I	2006-07-06
K061069	Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458	Helena Laboratories, Corp.	CFF	Class II	2006-07-06
K060569	Balanced Knee System Modular Revision Knee System	Ortho Development Corp.	JWH	Class II	2006-07-06
K060448	Lumenis One Family of Systems; Lumenis One.	Lumenis Ltd	GEX	Class II	2006-07-06
K053593	Prodigy	Diagnostic Devices, Inc.	NBW	Class II	2006-07-06
K053213	Bi-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos Foam	Berkeley Advanced Biomaterials	MQV	Class II	2006-07-06
K061694	Medcare Mechanical Wheelchair, Models Mc-281S & Mc-200S	Medcare Manufacturing, Inc.	IOR	Class I	2006-07-05
K061540	Leksell Gammaplan	Elekta Instrument AB	IWB	Class II	2006-07-05
K061474	Collawound Dressing	Collamatrix Co., Inc.	KGN	Unclassified	2006-07-05
K061390	Dimension Vista System Enzyme2 Calibrator, Model Kc320	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-07-05
K061386	Anchor Band Suturing System, Model Sr-Ab	Anulex Technologies, Inc.	GAT	Class II	2006-07-05
K061262	Ligafix Interference Screw	Sciences for Bio Materials	HWC	Class II	2006-07-05
K060970	Axyaloop Nonabsorbable Bone Anchor	TORNIER Inc.	JDR	Class II	2006-07-05
K053406	Barrierplus Gold Powder-Free Synthetic Polyisoprene Surgical Gloves	Barriermed Glove Co.	KGO	Class I	2006-07-05
K052354	Oculase Md	Biolase MG LLC	GEX	Class II	2006-07-05
K061769	E.p.t. Certainty 1-Step Pregnancy Test	Unipath, Ltd.	LCX	Class II	2006-07-03
K061603	Smoothshapes	Biocellulase, Inc.	NUV	Class II	2006-07-03
K061594	Large Uni-Clip Staple	New Deal, S.A.	JDR	Class II	2006-07-03
K061592	Modification to Cd Horizon System	Medtronic Sofamor Danek	NKB	Class II	2006-07-03
K061576	Modification to Quantum Vertebral Body Replacement System	Quantum Orthopedics, Inc.	MQP	Class II	2006-07-03