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 2077 of 3531

510(k) clearances, page 2077 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942109	The Hill Adjustable Rath Mechanical Table	Hill Laboratories	INQ	Class I	1995-06-22
K931167	Ovamed Fallopian Ostial Access Catheter	Ovamed Corp.	LKF	Class II	1995-06-22
K952455	Improved Manhattan II	Argosy Electronics	ESD	Class I	1995-06-21
K952454	Expander with Active Tone Control	Argosy Electronics	ESD	Class I	1995-06-21
K952453	Input Comprssion Limiter with Active Tone Control	Argosy Electronics	ESD	Class I	1995-06-21
K952403	Aurolite 80	Argen Precious Metals, Inc.	EJT	Class II	1995-06-21
K952064	Focus Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	LIT	Class II	1995-06-21
K952057	Listenaider II	National Hearing Aid Dist., Inc.	LZI	Class II	1995-06-21
K951911	Gauze, Nonabsorabable, X-Ray Detectable (Internal Sponge)	Commercial Resources New Mexico, Ltd.	GDY	Class I	1995-06-21
K951909	Rynel Medical Foam	Rynel, Ltd. Inc.	KMF	Class I	1995-06-21
K951871	Piston Syringe	Baxa Corp.	FMF	Class II	1995-06-21
K951854	Leonard Arm - Support Arm - Endoscopic Accessory	Leonard Medical, Inc.	FQO	Class I	1995-06-21
K951746	Forte Cb	Chattanooga Group, Inc.	IMG	Class II	1995-06-21
K951726	S-Rom Ztp Uhmwpe Acetabular Cup	Joint Medical Products Corp.	JDI	Class II	1995-06-21
K951546	Endopath and Proximate Linear Cutters and Staplers	Ethicon Endo-Surgery Inc	GCJ	Class II	1995-06-21
K951357	Ebi Small External Fixator (S/e/f/)	Electro-Biology, Inc.	KTT	Class II	1995-06-21
K951166	Bioderm Medical Hydrogel Island Dressing	Bioderm, Inc.	NAE	Class I	1995-06-21
K950851	Gent-L-Kare Tracheostomy Trays	Premium Plastics, Inc.	LRQ	Class I	1995-06-21
K950419	The Imed Orion Infusion Pump and Administration Sets	Imed Corp.	FRN	Class II	1995-06-21
K950095	Cybex 770	Cybex	IKK	Class II	1995-06-21
K950078	Microflow Irrigation System	JEDMED Instrument Company	KMA	Class I	1995-06-21
K946352	Lemaitre Valvulotome II	Vascutech, Inc.	MGZ	Class II	1995-06-21
K945994	Dual Purpose Catheter	Universal Medical Products, Inc.	BSY	Class I	1995-06-21
K945666	Evolution(tm) Microcatheter	Boston Scientific Corporation	KRA	Class II	1995-06-21
K944597	Graham-Field Ultrasound Scanning Gel	Chester Labs, Inc.	IYO	Class II	1995-06-21
K944567	Cowboy X	KCI USA, Inc.	JOW	Class II	1995-06-21
K944226	Msi Procedure Kit	Msi, Inc.	DOX	Class II	1995-06-21
K942391	Braun Manifold	B.Braun Medical, Inc.	DTL	Class II	1995-06-21
K941959	Versatell; Versatell-S	Progressive Concepts, Inc.	HCC	Class II	1995-06-21
K941793	Oxygen Concentration Status Indicator (O.c.s.i.)	Mountain Medical Equipment, Inc.	CCL	Class II	1995-06-21
K941473	Maxima Plus Hollow Fiber Oxygenator	Medtronic, Inc.	DTZ	Class II	1995-06-21
K952448	3.3Mm Accessories	Nobelpharma USA, Inc.	DZE	Class II	1995-06-20
K952319	Contrast & Rapid Hcg Urine/serum Tst	Medix Biotech, Inc.	JHI	Class II	1995-06-20
K952309	N Latex Iga	Behring Diagnostics, Inc.	CZP	Class II	1995-06-20
K952286	Amerlite Ferritin II Assay	Johnson & Johnson Clinical Diagnostics, Inc.	DBF	Class II	1995-06-20
K952246	Tri-Techin. Custom Blood And/or Urine Transport Kit	Tri-Tech, Inc.	JXA	Class I	1995-06-20
K952179	Synermed Ise Reagents	Synermed, Inc.	JGS	Class II	1995-06-20
K952130	Orgentec Anti-Tg Elisa	American Laboratory Products Company	JZO	Class II	1995-06-20
K952129	Orgentec Anti-Tpo Elisa	American Laboratory Products Company	JZO	Class II	1995-06-20
K952124	Abond	Parkell, Inc.	KLE	Class II	1995-06-20
K952123	Ms Emulsion	Parkell, Inc.	KLE	Class II	1995-06-20
K951983	Imni-II	Cottrell, Ltd.	LRJ	Class I	1995-06-20
K951710	Cedia Dau Benzodiazepine Assay	Microgenics Corporation	JXM	Class II	1995-06-20
K951368	Carbomedics Exended Mitral Rotator	Carbomedics, Inc.	MOP	Class I	1995-06-20
K951300	Nezhat-Dorsey Thermal Retention System	American Hydro-Surgical Instruments, Inc.	LHC	Class I	1995-06-20
K951259	Icel Ultrasonic Nebulizer Models Pu 12000 and Pu 12300	Impulso Trading Co.	CAF	Class II	1995-06-20
K951169	Ciba Corining Acs Theophylline Immunoassay	Ciba Corning Diagnostics Corp.	LGS	Class II	1995-06-20
K945836	1800 Monitoring ECG Electrode and 1870 Diaphoretic Monitoring ECG Electrodes	Conmed Andover Medical, Inc.	DRX	Class II	1995-06-20
K945446	Bobes Tonometer	Bobes S.A.	HKY	Class II	1995-06-20
K944860	Scholar Patient Monitor	Criticare Systems, Inc.	MHX	Class II	1995-06-20