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 1487 of 3531

510(k) clearances, page 1487 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023435	Meds-4 Neuromuscular Stimulator	Medical Equipment Device Specialists	GZJ	Class II	2003-01-13
K023163	Liquishield-S (0.7G), Model Ls 0010, Liquishield-S (2.0G), Model Ls 0020	Medlogic Global Limited	KMF	Class I	2003-01-13
K022636	Body Box 5500	Morgan Scientific, Inc.	JEH	Class II	2003-01-13
K021794	Tatung Tmd-26Ax Series TENS, Models No. Tmd-26Ab Tatung TENS (Blue Housing) Tmd-26Ay Tatung TENS (Yellow Housing)	Tatung Co.	GZJ	Class II	2003-01-13
K024226	Liquichek Anti-Scl-70 Control, Positive, Catalog #116	Bio-Rad	LKJ	Class II	2003-01-10
K024165	Dual-Lumen Catheter	Bistech, Inc.	EOQ	Class II	2003-01-10
K024114	A-Scan 100	Ophthalmic Technologies, Inc.	IYO	Class II	2003-01-10
K024083	Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor	Supermax Glove Manufacturing Sdn Bhd	LZA	Class I	2003-01-10
K023791	Nusoft Spherical, Toric, Aspheric and Bifocal (Ocufilcon B) Soft Contact Lenses for Daily Wear	Softfocal Company, Inc.	LPL	Class II	2003-01-10
K023721	Bonart Art-L2 Light Curing Unit	Bonart Co. Ltd.	EBZ	Class II	2003-01-10
K023183	Medrad Stellant CT Injector System	Medrad, Inc.	DXT	Class II	2003-01-10
K022078	Sola, Counter-Pulsation, Model Secp-S	Sola Medical Devices, LLC	DRN	Class II	2003-01-10
K021739	Limerick Powered Electric Breast Pump Model 1002	Limerick, Inc.	HGX	Class II	2003-01-10
K024354	Phsl-63-Sym and Phs-63-Sym Pediatric Head and Spine Array Coils	Mri Devices Corp.	MOS	Class II	2003-01-09
K024352	Hrh-127-8 Head Array Coil for Ge Signa 3T Excite MRI System	Mri Devices Corp.	MOS	Class II	2003-01-09
K024292	Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and Chemotherapy Labeling Claim	Medtronic, Inc.	LYY	Class I	2003-01-09
K024209	Qwh-250-Pan Wrist Array Coil	Mri Devices Corp.	MOS	Class II	2003-01-09
K024112	Bd Insulin Syringe	Becton Dickinson & Co	FMF	Class II	2003-01-09
K024095	Modification to Vision Sciences Endosheath System	Cogentix Medical, Inc.	EOB	Class II	2003-01-09
K024086	Propeller Head Small Cannulated Screw System	Biomet Orthopedics, Inc.	HWC	Class II	2003-01-09
K023960	Lidcoplus Hemodynamic Monitor System, Model Hm 70	Lidco Ltd	DXG	Class II	2003-01-09
K023864	Performa Stereo	Instrumentarium Corp. Imaging Division	IZH	Class II	2003-01-09
K023652	Remecure Model Cl 15E	Remedent NV	EBZ	Class II	2003-01-09
K023460	Pacsplus	Medical Standard Co., Ltd.	LLZ	Class II	2003-01-09
K022909	Nikomed Trace 1 ECG Electrodes	Nikomed U.S.A., Inc.	DRX	Class II	2003-01-09
K022622	Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P	Berkeley Advanced Biomaterials	MQV	Class II	2003-01-09
K021634	King Lt, Models # Klt 100, Klt 101, Klt 102, Klt 103, Klt 104, Klt 105	King Systems Corporation.	CAE	Class I	2003-01-09
K020863	Carto Xp and Qwikmap Ep Navigation System	Biosense Webster Inc	DQK	Class II	2003-01-09
K020784	Jostra Single Stage Venous Return Catheters	Jostra AG	DWF	Class II	2003-01-09
K024294	Modification to Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	2003-01-08
K024069	One Piece Pediatric Arterial Cannula, Model: 77006, 77106	Medtronic, Inc.	DWF	Class II	2003-01-08
K024059	Mbc Series	Soring GmbH Medizintechnik	GEI	Class II	2003-01-08
K024047	Erbe Vio Apc with Accessories	Erbe USA Inc	GEI	Class II	2003-01-08
K023895	Bd Phoenix Automated Microbiology System - Ciprofloxacin Gn	Becton Dickinson & Co	LON	Class II	2003-01-08
K023859	Smarttroae	Intelligent Hearing Systems Corp.	EWO	Class II	2003-01-08
K023481	Microvision Scleral Buckling Components	Microvision, Inc.	HQX	Class II	2003-01-08
K022272	Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)	Medtronic Cardiac Surgical Products	DWF	Class II	2003-01-08
K021694	Cardiovention Powerbase Console, Model Pbc-100	Cardiovention, Inc.	DTQ	Class II	2003-01-08
K021222	Lad, Model Lad-01	Norwood Abbey, Ltd.	GEX	Class II	2003-01-08
K024208	Obc-250-Pan Breast Array Coil	Mri Devices Corp.	MOS	Class II	2003-01-07
K023840	Acid Phosphatase Assay for the Advia 1650	Bayer Diagnostics Corp.	CKB	Class II	2003-01-07
K023728	Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color	Canopus Medical Supply Co., Ltd.	LYZ	Class I	2003-01-07
K023476	Unipacs Workstation	Universal Pacs, Inc.	LLZ	Class II	2003-01-07
K023467	Hcp Dicom Net	Softlink International, Inc.	LLZ	Class II	2003-01-07
K023427	Cardiassist Counterpulsation System, Model Mark 3000	Cardiomedics, Inc.	DRN	Class II	2003-01-07
K023394	Unisight System with Unigate	Electronic Business Machine Co., Ltd. (Ebm)	LLZ	Class II	2003-01-07
K022844	Synthes Resorbable Contourable Mesh	Synthes (USA) Products LLC	JEY	Class II	2003-01-07
K022023	Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500	Clinical Innovations, LLC	KLA	Class II	2003-01-07
K021338	Acculeaf	Direx Systems Corp.	IYE	Class II	2003-01-07
K021130	Specath Central Venous Catheter Kits	Special Medical Co., Ltd.	FOZ	Class II	2003-01-07