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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1723 of 3533

510(k) clearances, page 1723 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991551	Vacutainer Brand Sodium Citrate Pediatric Tube	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1999-09-23
K990960	Perimed Transcutaneous Po2 and Pco2 Monitor (Pf5040)	Perimed AB	LKD	Class II	1999-09-23
K990660	Nmt Neurosciences Control Unit, Model 910-600 & Nmt Neurosciences Disposable Drainage Line Kit, Model 910-6Xx	Nmt Neurosciences Implants S.A.	JXG	Class II	1999-09-23
K990241	Accuimage, Accuview Diagnostic Imaging, Workstation W/accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip	Accuimage Diagnostics Corp.	LLZ	Class II	1999-09-23
K972833	E100m Ventilator (E100m)	Newport Medical Instruments, Inc.	CBK	Class II	1999-09-23
K993069	Ge Diasonics Gateway and Gateway Fx	General Electric Co.	IYO	Class II	1999-09-22
K992951	Convertors Surgical Gowns	Medtronic, Inc.	FYA	Class II	1999-09-22
K992705	Ceradium Non-Precious Ceramic Alloy	Matech, Inc.	EJH	Class II	1999-09-22
K992645	Sinfony	Espe Dental AG	EBF	Class II	1999-09-22
K992611	Mitek Rotator Cuff Quickanchor Plus	Mitek Products	HWC	Class II	1999-09-22
K992609	Hydro-Cast Silicone Soft-Liner, Model 68400	Kay See Dental Mfg. Co.	EBI	Class II	1999-09-22
K992518	Prime & Bond Nt Dual Cure Universal Dental Adhesive System	Dentsply Intl.	EBC	Class II	1999-09-22
K992405	Axya Medical Inc, Bone Anchor System and Kit- (Bak)	TORNIER Inc.	GAW	Class II	1999-09-22
K992374	Aurora Hl	Premier Laser Systems, Inc.	GEX	Class II	1999-09-22
K992364	Health-Plus, Sanitex, Reliance Power-Free Latex Examination Glove with Protein Content Labeling Claim 73.13 Micrograms O	Pamitex Industries Sdn Bhd	LYY	Class I	1999-09-22
K992350	Pylon Intramedullaary Nail System	Alphatec Spine, Inc.	HSB	Class II	1999-09-22
K992306	Samsung Raypax Display Workstation	Samsung Sds Co., Ltd.	LLZ	Class II	1999-09-22
K992161	Cerana	Nordiska Dental AB	EIH	Class II	1999-09-22
K992144	Biopro Rimmed Acetabular Compoment	Biologically Oriented Prostheses	LZO	Class II	1999-09-22
K991577	Nic Tone Acrylic Resins	Manufacturera Dental Continental	EBI	Class II	1999-09-22
K991398	Bonesource Hydroxyapatite Cement (Hac) Expanded Kit	Stryker Leibinger	GXP	Class II	1999-09-22
K991209	Oral Sleep Disorder Aid	Perl-Rad Sleep Disorder Lab	LRK	Class II	1999-09-22
K992963	I3rad 125 I Brachytherapy Seed, Model I125-0401	International Isotopes, Inc.	KXK	Class II	1999-09-21
K992947	Cannulated Smartscrew Models 224540C, 224570C	Bionx Implants, Inc.	HWC	Class II	1999-09-21
K992928	Cd Horizon Spinal System	Sofamor Danek USA,Inc.	MNI	Class II	1999-09-21
K992763	Sysmex Automated Coagulation Analyzer, Model Ca-500	Siemens Healthcare Diagnostics Inc.	GKP	Class II	1999-09-21
K992528	Biocheck Ige Elisa, Model Bc-1035	BioCheck Inc	DGC	Class II	1999-09-21
K992487	Mitek Mini Quickanchor Plus	Mitek Products	HWC	Class II	1999-09-21
K992440	Autostat II Anti-Cardiolipin Igg Elisa	Cogent Diagnotics, Ltd.	MID	Class II	1999-09-21
K992423	Sysmex Automated Coagulation Analyzer, Model Ca-500	Siemens Healthcare Diagnostics Inc.	GKP	Class II	1999-09-21
K992296	Pasco Mic and Mic/id Panels, Vancomycin	Pasco Laboratories, Inc.	JWY	Class II	1999-09-21
K992199	Acid Hemoglobin Kit	Helena Laboratories, Corp.	JBD	Class II	1999-09-21
K991399	Radionics Microelectrode Kit	Radionics, Inc.	GXI	Class II	1999-09-21
K991319	Raycast Immobilization Systems Hardware and Thermoplastic Materials	Orfit Industries NV	IYE	Class II	1999-09-21
K991063	Qualicode B. Burgdorferi Igg Western Blot Kit, Model Dk-C052-024	Immunetics, Inc.	LSR	Class II	1999-09-21
K991062	Qualicode B. Burgdorferi Igm Western Blot Kit, Model Dk-C062-024	Immunetics, Inc.	LSR	Class II	1999-09-21
K991045	Mini-Logger Series 2000	Mini-Mitter Co., Inc.	GWK	Class II	1999-09-21
K992990	Quickpac II One Step Cocaine Test	Syntron Bioresearch, Inc.	DIO	Class II	1999-09-20
K992559	Hollow Fiber Membrane Oygenator Quadrox Hmo 1010	Jostra Bentley	DTZ	Class II	1999-09-20
K992370	Amplaid A724 and A728	Amplifon	ETY	Class II	1999-09-20
K992124	Avanti Polar Lipids Vdrl Antigen Slide Test Kit with 10 X 0.5 Ml Ampules, Avanti Polar Lipids Bulk Bdrl Antigen, Avanti	Avanti Polar Lipids, Inc.	GMQ	Class II	1999-09-20
K990378	Statview System	Data Critical Corp.	MSX	Class II	1999-09-20
K992903	Color Buffed Cemented Femoral	Zimmer GmbH	JDI	Class II	1999-09-17
K992873	Lorenz External Mandibular Distractor	Biomet Microfixation	MQN	Class II	1999-09-17
K992772	Cardiophonics 1000 Memory Monitor	Rlt Medical Assoc., Inc.	DXH	Class II	1999-09-17
K992670	Oxygen Enrichment Kit, Models Sg 066, Sg 067	Instrumentation Industries, Incorporated	CBK	Class II	1999-09-17
K992488	Total Haemolytic Complement Rid Kit	The Binding Site	DAE	Class II	1999-09-17
K992381	CO2 Gas Warmer II, Model 6-800-00	Northgate Technologies Inc.	HIF	Class II	1999-09-17
K992321	Sysmex Automated Coagulation Analyzer, Model Ca-6000	Siemens Healthcare Diagnostics Inc.	GKP	Class II	1999-09-17
K992129	Phazx Vld-100	Phazx Systems, Inc.	GZO	Class II	1999-09-17