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 3417 of 3526

510(k) clearances, page 3417 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782132	Plethysmograph, Strain Gauge	Medasonics, Inc.	JOM	Class II	1979-02-26
K782124	Iec Centra-7 Centrifuge Model 2362	Damon Corp.	JQC	Class I	1979-02-26
K782119	Debutron	Martin Electric Co.	KCX	Class I	1979-02-26
K782039	Seracon-N	Bhp Diagnostix, Inc.	JIX	Class II	1979-02-26
K781949	Electrosurgery Model 771	Birtcher Corp.	GEI	Class II	1979-02-26
K781799	EKG, Switching Blade and Pens	Bionex, Inc.	GEI	Class II	1979-02-26
K790258	Movable Core Safety Guide	Cordis US Corp.	DQX	Class II	1979-02-23
K790241	Intra-Aortic Balloon-Pump	Avco Medical Products	DSP	Class II	1979-02-23
K790144	Telemetry System 315	GE Medical Systems Information Technologies, Inc.	DRG	Class II	1979-02-23
K782073	Dinamap Models 1160 and 1165	Applied Medical Research	DSK	Class II	1979-02-23
K782072	Quinton Status 1000	Quinton, Inc.	DQK	Class II	1979-02-23
K790352	Nephross 11F100	Redy Laboratories			1979-02-22
K790307	Flexible Reamer, Guide Wire System	3M Company	HTO	Class I	1979-02-22
K790306	Edge Protector, Barrier	Surgikos, Inc.	KGW	Class II	1979-02-22
K790234	Drape Packs, Surgical Gowns	Convertors	KKX	Class II	1979-02-22
K790175	Semi-Reclining Bath Chari & Belt	Fred Sammons, Inc.	ILS	Class I	1979-02-22
K790173	Bk-5371 Gad-19-Bout Personal Mobil Aid	Fred Sammons, Inc.	IKW	Class I	1979-02-22
K790073	Analyzer, Impact 100	Gilford Instrument Laboratories, Inc.	JJI	Class I	1979-02-22
K790072	Analyzer, Impact 200	Gilford Instrument Laboratories, Inc.	JJE	Class I	1979-02-22
K790055	Tubing, Dynacor Universal	MEDLINE INDUSTRIES, LP - Northfield	GCX	Class II	1979-02-22
K790045	Reagent Kit, Chloride/carbon Dioxide	J.T. Baker Chemical Co.	JFS	Class II	1979-02-22
K790044	Reagent Kit, Bakers Diagnostic	J.T. Baker Chemical Co.	CGX	Class II	1979-02-22
K790041	Accessory Kit, Centrifichem	Union Carbide Corp.	JQW	Class I	1979-02-22
K782168	3-Way Stopcock	Medex, Inc.	FMG	Class II	1979-02-22
K782151	Artificial Kidney, C-Dak 0.6D	Cordis US Corp.	FJI	Class II	1979-02-22
K782143	Ria Kit, Glucose	Serono Laboratories, Inc.	JME	Class I	1979-02-22
K790312	Endotracheal Tube W/holder & Connector	Respiratory Support Products, Inc.	BTR	Class II	1979-02-21
K790299	Forearm-Cane	Guardian Products Co., Inc.	IPS	Class I	1979-02-21
K790275	Gun, Exeter Cement	Howmedica Corp.	KIH	Class I	1979-02-21
K790232	Agar, Motility-Nitrate	Los Angeles Biological Products	JSE	Class I	1979-02-21
K790231	Decarboxylase, Buffered Lysine	Los Angeles Biological Products	JSF	Class I	1979-02-21
K790230	Dentrification Lactose Agar	Los Angeles Biological Products	JSE	Class I	1979-02-21
K790225	Limb Sheet with Fabric 450	Surgikos, Inc.	KKX	Class II	1979-02-21
K790134	Radiotherapy Treatment	General Electric Co.	JAK	Class II	1979-02-21
K790132	Tecnotomo	Teknomed, Inc.	IZF	Class II	1979-02-21
K790121	Film-X 90	Automatic Film Processor Corp.	IXW	Class II	1979-02-21
K790065	Alkaline Phosphatase	Macomb Chemical Co.	CJE	Class II	1979-02-21
K782167	Delta Flow	Medex, Inc.	FMG	Class II	1979-02-21
K782139	Zylox	Premier Dental Products Co	ELW	Class II	1979-02-21
K782093	Detector Pad	Halperin Institute, Ltd. the	KPN	Class II	1979-02-21
K781966	Dialyzer, Magniflo 100 Parallel Plate	Erika, Inc.	FJG	Class II	1979-02-21
K781380	Marne M.t.p.j. Orthopedic Implant	Farah, Ltd.	KYJ	Class II	1979-02-21
K790224	Padiatry Pack & Sheet with Fabric 450	Surgikos, Inc.	KKX	Class II	1979-02-16
K790185	Model V 4207 Integrating Plug-in	Electronics for Medicine, Inc.	BZC	Class II	1979-02-16
K790163	Aerosol Mask	Airlife, Inc.	BYG	Class I	1979-02-16
K790139	Monitor, Office Model 140	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1979-02-16
K790091	Amp Automatic Cycler Stand	American Medical Products LLC	KPF	Class II	1979-02-16
K790064	Tinnitus Devices	Vicon Instrument Co.	ETS	Class II	1979-02-16
K790061	Needle, Burron Filter	National Patent Development Corp.	GAA	Class I	1979-02-16
K782107	Lap Sponge	Carapace, Inc.	GDY	Class I	1979-02-16