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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3402 of 3526

510(k) clearances, page 3402 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791186	Model Bp-2000 Time-Cycled Ventilator	Bourns Medical Systems, Inc.	CBK	Class II	1979-07-06
K790963	Paint-on Restorative, Light Cured	Scientific Pharmaceuticals, Inc.	EBF	Class II	1979-07-06
K790962	Seal & Bond Direct Bonding Orthodontic	Scientific Pharmaceuticals, Inc.	DYH	Class II	1979-07-06
K790822	Anterior/posterior Restorative Liquid	Scientific Pharmaceuticals, Inc.	EBF	Class II	1979-07-06
K790789	Composite Restorative, Paste/paste Type	Scientific Pharmaceuticals, Inc.	EBF	Class II	1979-07-06
K790788	Fissure Sealer and Bonding Agent	Scientific Pharmaceuticals, Inc.	EBC	Class II	1979-07-06
K791188	Cam-10 Battery Pack (#7-001)	Lifecare Services, Inc.	CBK	Class II	1979-07-05
K790870	Model H63, Behind-the-Ear	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-07-05
K790429	Medtronic Model 6957	Medtronic, Inc.	DTB	Class III	1979-07-05
K791221	Tegtmeier Mammometer	Aztec Medical Products, Inc.			1979-07-03
K791158	Stimulator, Electrical Nerve	Electreat, Inc.	GZJ	Class II	1979-07-03
K791086	Centry 2 System #016, 103, 016, 104	Cobe Laboratories, Inc.	FIP	Class II	1979-07-03
K791071	Model Ma3 Behind-the-Ear Masker/hearing	Starkey Laboratories, Inc.	KLW	Class II	1979-07-03
K791048	Stimtech Neuromuscular Stimulator, C 600	Stimulation Technology, Inc.	IPF	Class II	1979-07-03
K791033	Cam-10 Pvv Portable Volume Ventilator	Lifecare Services, Inc.	CBK	Class II	1979-07-03
K791017	Flow Limiter	Timeter Instrument Corp.	CAX	Class I	1979-07-03
K790970	Surgical Face Mask	Carapace, Inc.	KKX	Class II	1979-07-03
K790914	Silastic Intravenous Catheter Unit	Dow Corning Corp. Healthcare Industries Materials	FOZ	Class II	1979-07-03
K790658	Aircraft Transit Isolator Model 121	Vickers America Medical Corp.	LGN	Class II	1979-07-03
K790657	Stretcher Transit Isolater #122	Vickers America Medical Corp.	LGM	Class II	1979-07-03
K790605	Respiraotr, Cam-10 Rbl	Lifecare Services, Inc.	CBK	Class II	1979-07-03
K791135	Lyophilized G-Hb Quik Column Control	Helena Laboratories, Corp.	LCP	Class II	1979-06-28
K791113	Low Ionic Strength Solution (Liss)	Hyland Therapeutic Div., Travenol Laboratories	KSG	Class II	1979-06-28
K791103	Leeco Glyco-Hemoglobin Diagnostic Kit	Leeco Diagnostics, Inc.	LCP	Class II	1979-06-28
K791049	Synalon Roller Bottle	Dynatech Laboratories, Inc.	KJC	Class I	1979-06-28
K791023	Prothrombin Free Beef Plasma (Pfb)	Pacific Hemostasis	GJS	Class II	1979-06-28
K790986	RF Controls	Wampole Laboratories	DMR	Class I	1979-06-28
K790965	Reagent Strips for Urinalysis	Miles Laboratories, Inc.	CDM	Class I	1979-06-28
K790961	Liquid Scintillation Counter	Nuclear Ent., Ltd.	JJJ	Class I	1979-06-28
K790958	120 Well Histo-Plate	Dynatech Laboratories, Inc.	KIZ	Class I	1979-06-28
K790947	Auto Enzymatic Cholesterol	Macomb Chemical Co.	CHH	Class I	1979-06-28
K790944	Citrate Agar Gel and Buffer Set	Corning Medical & Scientific	JBD	Class II	1979-06-28
K790919	Hpl Ria Kit	Technia Diagnostics, Ltd.	JMF	Class II	1979-06-28
K790865	Lancer Hdl Separation Kit	Sherwood Medical Co.	LBR	Class I	1979-06-28
K790862	Biovation Digital Urinometer	Biovation, Inc.	JRE	Class I	1979-06-28
K790840	Thyroid Control Sera Code Qas.101	Amersham Corp.	JJY	Class I	1979-06-28
K790834	UV Uric Acid Determination	The Dow Chemical Co.	CDO	Class I	1979-06-28
K790813	Multecon Blood Gas Control	Ortho Diagnostics, Inc.	JJS	Class I	1979-06-28
K790812	Coulter Accu-Zyme Iiy-Gt Reagent Kit	Coulter Electronics, Inc.	JPZ	Class I	1979-06-28
K790803	Syringe Tonometer	Medicor USA, Ltd.			1979-06-28
K790753	Dimensionall Rotator	American Hospital Supply	JRQ	Class I	1979-06-28
K790445	Ultra-Free	EMD Millipore Corporation	JRL	Class I	1979-06-28
K791157	360 Hemoclip Appliers	Edward Weck, Inc.	GDO	Class I	1979-06-27
K791125	Plug-Lok Cement Restirctor	Richard'S Medical Equip., Inc.	LZN	Class II	1979-06-27
K791124	Surgical Scissors	Xomed, Inc.	KBD	Class I	1979-06-27
K791121	Alligator Forecpts, Cupped Forceps	Xomed, Inc.	JYR	Class I	1979-06-27
K791069	Linde Oxygen Therapy Flowmeters, L33-L34	Union Carbide Corp.	CAX	Class I	1979-06-27
K791020	Fluid Administration Set Fa-3160	Burron Medical Products, Inc.	EYN	Class II	1979-06-27
K791016	Ulticare 2500 Treatment Chair	American Health Care Industries, Inc.	FRK	Class I	1979-06-27
K790996	C.c.f. Femoral Debridement Probe	Depuy, Inc.	HTO	Class I	1979-06-27