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 1754 of 3531

510(k) clearances, page 1754 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990886	Immulite C-Reactive Protein, Model Lkcr1, Lkcr5	Siemens Healthcare Diagnostics Inc.	DCK	Class II	1999-04-06
K990863	Modification to Flexflo Polyg Gastrostomy Tube	Ross Product Div. Abbott Laboratories	KNT	Class II	1999-04-06
K990817	Ips D.sign Porcelain	Ivoclar North America, Inc.	EIH	Class II	1999-04-06
K990737	'Ecurline Umbilical Cord Clamp #3500	Precision Dynamics Corporation	HFW	Class II	1999-04-06
K982640	Medex 3000 Series Syringe Infusion Pump	Medex, Inc.	FRN	Class II	1999-04-06
K982029	Sharps Collection Container - Saf-T-Shell	American Medical Mfg., Inc.	FMI	Class II	1999-04-06
K990567	Global Healthcare Self-Sealing Sterilization Pouch	Global Healthcare, Inc.	FRG	Class II	1999-04-05
K990491	Angio-CT Miyabi	Siemens Medical Solutions USA, Inc.	IXI	Class II	1999-04-05
K981036	Smartbond	Gac Intl., Inc.	DYH	Class II	1999-04-05
K990091	S.p.a.r Sterile Ambulatory Reservoir	Faulding Pharmaceutical Co.	MRZ	Class II	1999-04-04
K990064	Di-Rhex Ophthalmic Diathermy System	Ophthalmic Technologies, Inc.	HQR	Class II	1999-04-04
K990790	Vision Porcelain	Servo Dental USA, Inc.	EIH	Class II	1999-04-02
K990749	Sof-Suction Fluid Evacuation System	X-Tech Medical Ltd	HOZ	Class II	1999-04-02
K990726	Envy Guiding Catheter	Cook Inc.	DQY	Class II	1999-04-02
K990670	Helioform Gold-Based Alloy	C. Hafner GmbH & Co.	EJT	Class II	1999-04-02
K990502	Prepowdered Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less)	Flexitech Sdn. Bhd.	LYY	Class I	1999-04-02
K990501	Powder Free Latex Examination Gloves, W/ Protein Labeling Claim	Flexitech Sdn. Bhd.	LYY	Class I	1999-04-02
K990499	Prepowdered Nitrile Examination Gloves	Flexitech Sdn. Bhd.	LZA	Class I	1999-04-02
K990495	Powder Free Nitrile Examination Gloves	Flexitech Sdn. Bhd.	LZA	Class I	1999-04-02
K990314	Multi-Cure Composite Cement	Medental Intl.	EBF	Class II	1999-04-02
K990004	Dci Endoscope	Karl Storz Endoscopy-America, Inc.	HET	Class II	1999-04-02
K984513	Trovafloxacin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1999-04-02
K984422	Sterile Back Surgical Gown with Hand Towel	Medical Sterilization, Inc.	FYA	Class II	1999-04-02
K983997	Sterichek Total Chlorine Test Kit	Environmental Test Systems, Inc.	MSY	Class II	1999-04-02
K983467	Therapep	Dhd Healthcare Corp.	BWF	Class II	1999-04-02
K983343	Plato Brachytheraphy, Model V. 14.0	Nucletron BV	MUJ	Class II	1999-04-02
K983337	Rotterdam Nasophayrnx Mould Set, Part #089.068	Nucletron BV	JAQ	Class II	1999-04-02
K983115	Treatment Control Station - Microselectron-Hdr Classic Upgrade, Version 1.20	Nucletron BV	JAQ	Class II	1999-04-02
K983022	Smartcell Processing System	Terumo BCT, Ltd	CAC	Class II	1999-04-02
K982708	Spq Test System	Diasorin Inc.	DFC	Class II	1999-04-02
K982505	Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination Glove	Tillotson Healthcare Corp.	LYY	Class I	1999-04-02
K981535	Focus Pilot Contouring Workstation	Elekta Limited	IYE	Class II	1999-04-02
K980745	Second Wind Air Purifier	Monagan Ent., Inc.	FRA	Class II	1999-04-02
K990952	Novafil and Vascufil Sterile Synthetic Non-Absorbable Sutures	United States Surgical, A Division of Tyco Healthc	GAT	Class II	1999-04-01
K990951	Maxon** Sterile, Synthetic, Absorbable Suture	United States Surgical, A Division of Tyco Healthc	GAM	Class II	1999-04-01
K990352	Coulter Ac T Diff 2 Analyzer	Coulter Corp.	GKZ	Class II	1999-04-01
K990322	Perry Humeral Nail	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HSB	Class II	1999-04-01
K990307	Omni-Fix, Nail System	Turnkey Intergration USA, Inc.	KTW	Class II	1999-04-01
K990256	Crx World Shunt	Phoenix Biomedical Corp.	JXG	Class II	1999-04-01
K990188	Intuitive Surgical Stereo View Endoscopic System, Model Svs-1	Intuitive Surgical, Inc.	GCJ	Class II	1999-04-01
K990185	Mdilog, Model Mdc-512	Medtrak Technologies, Inc.	CAF	Class II	1999-04-01
K990174	Atlas-Elite,model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV	Fisma, Inc.	GEX	Class II	1999-04-01
K990028	Endopath Optiview Optical Surgical Obturator and Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1999-04-01
K990007	Opart, Model Mrt-600	Toshiba America Mri, Inc.	MOS	Class II	1999-04-01
K990002	Quickray Dsx 730	Julie Alliance	MUH	Class II	1999-04-01
K984355	Point Setter	Mitaka USA, Inc.	GCJ	Class II	1999-04-01
K983524	Lares Research Sunlase 800P Laser System (to Be Sold as Peiolase for Laserenap)	Lares Research	GEX	Class II	1999-04-01
K982696	Interplant	Burdette Medical Systems, Inc.	MUJ	Class II	1999-04-01
K990923	Tubingen Titanium Prosthesis (Ttp) Vario, Models Aerial 1004 010 & Bell 1002 010	Heinz Kurz	ETB	Class II	1999-03-31
K990664	Prima System - Old, Bartels Elisa - New	Intracel Corp.	LLH	Class I	1999-03-31