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 2026-11-02, 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 1005 of 3531

510(k) clearances, page 1005 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100718	Audit Microcv Ammonian/ethanol Linearity Set, Model K712m-5	Aalto Scientific Ltd.	JJY	Class I	2010-09-03
K100455	Spaplus Analyzer	The Binding Site	DBI	Class II	2010-09-03
K100418	Superior Starburst Reusable Self-Adhering Tens/nmes/fes Stimulating Electrode	Medtronic, Inc.	GXY	Class II	2010-09-03
K091125	Clearwave Phototherapy System for Acne, Model: Cwst2	Verilux	ONE	Class II	2010-09-03
K102178	Easy Touch	MHC Medical Products	FMF	Class II	2010-09-02
K101567	Sharps Container	Cixi Leinuo Plastic Co., Ltd.	MMK	Class II	2010-09-02
K101326	Nmi Ic	Boston Scientific Corporation	LJS	Class II	2010-09-02
K101310	Vu Apod Intervertebral Body Fusion Device	Theken Companies LLC	OVD	Class II	2010-09-02
K101130	BIPAP Synchrony 2 with Af531 Full Face Mask	Respironics, Inc.	MNS	Class II	2010-09-02
K101034	Niox Mino Model 09-1000	Aerocrine AB	MXA	Class II	2010-09-02
K100795	Jet-X Bar System Clamps and Posts Reprocessing	Smith & Nephew, Inc.	KTT	Class II	2010-09-02
K100243	Quintex Cervical Plating System	Aesculap Inc	KWQ	Class II	2010-09-02
K093430	Exactech Equinoxe Xl Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd.	Exactech, Inc.	KWS	Class II	2010-09-02
K092736	Euroimmun Anti-M2-3E Elisa (Igg)	Euroimmun US Inc.	DBM	Class II	2010-09-02
K091969	Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)	Euroimmun US Inc.	NBO	Class II	2010-09-02
K102176	Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3Fc12, 3Fc10	Medtronic CryoCath LP	DRA	Class II	2010-09-01
K102020	Vega Span Spinous Process Plate System	SPINEFRONTIER, Inc. dba LESspine Innovations	KWP	Class II	2010-09-01
K102016	Precicontrol Clinchem Multi 1 and 2	Roche Diagnostics GmbH	JJY	Class I	2010-09-01
K101860	Novabone Putty- Bioactive Synthetic Bone Graft	Novabone Products, LLC	MQV	Class II	2010-09-01
K101602	Vital Signs Monitor	Criticare Systems, Inc.	MLD	Class II	2010-09-01
K101532	Nessi OTC Spacer	Pharmacaribe LLC	NVO	Class II	2010-09-01
K101506	Lux1540, Lux1440 & Lux2940 Laser Handpieces	Palomar Medical Technologies, Inc.	ONG	Class II	2010-09-01
K102155	Mr Radiation Oncology Options	GE Healthcare	LNH	Class II	2010-08-31
K102044	Elecsys Digoxin Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-08-31
K102014	TENS Stimulator, Models 2800 and 3000	Koalaty Products, Inc.	GZJ	Class II	2010-08-31
K101950	Fully Automatic Electronic Blood Pressure Monitor Model Kd-930	Andon Health Co., Ltd	DXN	Class II	2010-08-31
K101878	Ge Logiq P5 Model H44662ld	GE Healthcare	IYN	Class II	2010-08-31
K101714	Nobelprocera Ti Abutment Thommen Platforms	Nobel Biocare AB	NHA	Class II	2010-08-31
K101605	Mylabone Ultrasound System	Esaote Europe B.V.	IYN	Class II	2010-08-31
K101600	Intellivue Cl Sp02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216, Intellivue Patient Monitors Mp5, Mp2, X2 Model	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	DQA	Class II	2010-08-31
K101339	Archer Super Stiff Guidewires	Medtronic, Inc.	DQX	Class II	2010-08-31
K101226	Audit Microcv Rf/crp Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2010-08-31
K101070	Expedium Spine System	Medos International SARL	NKB	Class II	2010-08-31
K100749	Frequencer Model V2x	Dymedso, Inc.	BYI	Class II	2010-08-31
K100518	Instrumed Vessel Dilators, Model 65-7Xx,65-9Xxx,66-1Xxx,65-7048-65-7054	Instrumed International Inc dba Avalign German Specialty Instruments	DWP	Class II	2010-08-31
K100307	Gelscan, Model 1206	Sebia, Inc.	CFE	Class II	2010-08-31
K100124	Fastx Sternal Intraosseous Device	Pyng Medical Corp.	FMI	Class II	2010-08-31
K100102	Cs-Series-Fp	Omega Medical Imaging, LLC	OWB	Class II	2010-08-31
K093689	1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans	Mr Medical Solutions, LLC	MOS	Class II	2010-08-31
K091539	Iq 200 Urine Analizer Body Fluids Module	International Remote Imaging Systems	GKL	Class II	2010-08-31
K102169	Cyberwand Lithotripter	Cybersonics, Inc.	FFK	Class II	2010-08-30
K101810	3Dhjd Camera System Model	Vision Systems Group, A Division of Viking Systems	GCJ	Class II	2010-08-30
K101287	Tephaflex Composite Mesh	Tepha, Inc.	OWT	Class II	2010-08-30
K100998	1Ml Unitract 27G X 1/2 Tuberculin Syringe, Model 132By2-1	Unilife Medical Solutions Limited	MEG	Class II	2010-08-30
K100448	Ascension Modular Total Shoulder System	Ascension Orthopedics, Inc.	KWS	Class II	2010-08-30
K100055	Blood Pressure Meter, Model Ch-609	Citizen Systems Japan Co., Ltd.	DXN	Class II	2010-08-30
K093725	Cystoscope, Models Ce0004-C, Ce006-C, Ce3004-C, Ce3027-C, Ce7004-C, Ce1204-C, Ce1227-C	Canada Endoscope Corporation	FAJ	Class II	2010-08-30
K092449	Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2010-08-30
K102157	Elecsys Precicontrol Multimarker	Roche Diagnostics GmbH	JJY	Class I	2010-08-27
K102129	Levitronix 2Nd Generation Centrimag Primary Console, Levitronix Monitor	Levitronix, LLC	DWA	Class II	2010-08-27