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 2149 of 3531

510(k) clearances, page 2149 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944186	Sinuscope	Stryker Corp.	EOB	Class II	1994-11-07
K944163	Spectrum Disigns Pectoral Implant	Spectrum Designs, Inc.	MIC	Class II	1994-11-07
K943985	Limited Reuse Blades	Linvatec Corporation	HRX	Class II	1994-11-07
K943435	Cholangiography Set	Karl Storz Endoskop GmbH	GCJ	Class II	1994-11-07
K943355	Gemnet	GE Healthcare	IZI	Class II	1994-11-07
K943327	Conmed Selectone Minimal Access Surgery Instruments	Conmedcorp	GCJ	Class II	1994-11-07
K943141	B-D Guardian Point of Use Horizontal and Side Entry Sharps Collectors	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K943140	B-D Guradian Chemotherapy Sharps Collectors	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K943137	B-D/bfi Mail Disposal Service	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K943136	B-D Guardian Point-of-Use Vertical Entry Sharps Collectors	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K943135	Med-Safe Insulin Sharps Container	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K943134	B-D Guardian Nestable Sharps Collectors	Med-Safe Systems, Inc.	FMI	Class II	1994-11-07
K942508	Robo	Permobil, AB	INI	Class II	1994-11-07
K942400	Bard Peripheral Balloon Dilatation Catheter	C.R. Bard Inc	LIT	Class II	1994-11-07
K942311	Dynasty U1-33 Agm	Foley & Lardner	KNN	Class I	1994-11-07
K942310	Dynasty Gc 12550 (Gell/cell)	Foley & Lardner	KNN	Class I	1994-11-07
K942309	Dynasty U1-31 (Gell/cell)	Foley & Lardner	KNN	Class I	1994-11-07
K942308	Dynasty Gc 12400 (Gell/cell)	Foley & Lardner	KNN	Class I	1994-11-07
K941896	Steadman Ligament Graft Passer and Protector	Depuy, Inc.	LXH	Class I	1994-11-07
K941093	Smartpacs Filmless Reading and Image Distribution System and Consultation Station	Smartpacs	LLZ	Class II	1994-11-07
K940556	Sandoz Nutrition Compat(r) Enteral Feeding Pump	Sandoz Nutrition	LZH	Class II	1994-11-07
K940541	Magnetic Resonance Diag Device Magnetom Vision (Modif)	Siemens Medical Solutions USA, Inc.	LNH	Class II	1994-11-07
K935560	Pmt External External Drainage System (Eds)	PMT Corp.	JXG	Class II	1994-11-07
K933101	The Osteomed B Power System and Accessories	Osteomed	KIJ	Class I	1994-11-07
K931267	Convertors ISO Bac Drape Material	Baxter Healthcare Corporation	KKX	Class II	1994-11-07
K921995	Candela H:erb Laser	Candela Corporation	GEX	Class II	1994-11-07
K945102	Mta:angenieux Starpoint Xe Xenon Light Source	Alm Surgical Equipment, Inc.	FFS	Class II	1994-11-04
K945023	Origin Pixie Stic Introducer Sleeve	Origin Medsystems, Inc.	GCJ	Class II	1994-11-04
K944959	Amplatz Super Stiff Guidewire	Boston Scientific Corporation	OCY	Class II	1994-11-04
K944942	Breast Lesion Localization Needle	Promedical, Ltd.	GDF	Class I	1994-11-04
K944923	Ckmb/myoglobin Mass Measuremeny Control Level 1, 2, 3,	Clinical Controls, Inc.	JJT	Class I	1994-11-04
K944686	Fiberoptic Laryngoscope Handle	Fiberoptic Medical Products, Inc.	CCW	Class I	1994-11-04
K944324	Sure-Lock Ventilator Tubing Holder	B & B Medical Technologies, Inc.	BTR	Class II	1994-11-04
K944166	Dorsal Columella Implant	Spectrum Designs, Inc.	LZK	Class II	1994-11-04
K944165	Silhouette Malar Implant	Spectrum Designs, Inc.	LZK	Class II	1994-11-04
K944164	Meniscus Chin Implant	Spectrum Designs, Inc.	LZK	Class II	1994-11-04
K943998	Cannabinoid Eia Assay	Diagnostic Reagents, Inc.	LDJ	Class II	1994-11-04
K943680	Nce Replacement Batteries	National Custom Ent., Inc.	FCO	Class I	1994-11-04
K943632	Replacement Batteries	National Custom Ent., Inc.	FCO	Class I	1994-11-04
K942851	Smile Integrated Prophylaxis Paste Rings	Germiphene Corp.	EJR	Class I	1994-11-04
K942425	Proxiderm (Tentative)	Progressive Surgical Products, Inc.	MKY	Class I	1994-11-04
K942321	Variouspatient Monitoring Cable	Merit Cables Incorporated	DSA	Class II	1994-11-04
K942249	Clarus Neuropen Model 2120	Clarus Medical Systems, Inc.	GWG	Class II	1994-11-04
K941568	K-10-Vs, Da-05-Vs, Recording Electrodes	Medicotest, Inc.	GXY	Class II	1994-11-04
K940703	Medtronic Model 4558M	Medtronic, Inc.	DTB	Class III	1994-11-04
K936046	Sigma Elite	Penlon, Ltd.	CAD	Class II	1994-11-04
K935519	Etest for Ampicillin/sulbactam 2/1	Ab Biodisk North America, Inc.	JWY	Class II	1994-11-04
K934861	Hard Tissue Replacement (Htr) Granular	Poly-Medics,Inc.	KKY	Class II	1994-11-04
K933694	Sigma Glucose Reagent	Sigma Chemical Co.	CGA	Class II	1994-11-04
K932138	Saline for Irrigation	Rantran, Inc.	JOL	Class II	1994-11-04