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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3233 of 3528

510(k) clearances, page 3233 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820929	Rpmi-164Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820928	Ebs Powder	Dutchland Laboratories, Inc.	KIP	Class I	1982-04-21
K820927	Hbs Powder	Dutchland Laboratories, Inc.	KIP	Class I	1982-04-21
K820926	E-Bme Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820925	H - Bme Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820924	Hams F-12 Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820923	Dulbecco's Pbs Powder	Dutchland Laboratories, Inc.	KIP	Class I	1982-04-21
K820922	Hams F-10 Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820921	D-Mem-Low Glucose-Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820920	Mccoy's 5A Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820919	Earle's-199 Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820918	Hmem Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820917	L-15 Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820916	D-Mem-High Glucose-Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820915	Mem Autoclavable Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820914	Emem Powered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820904	EKG Telephone Converter	Dart Medical Equipment	DXH	Class II	1982-04-21
K820898	Vasculab Spectrum Analyzer #Sp25	Medasonics, Inc.	DXG	Class II	1982-04-21
K820896	Ventrex 125I Anti-Ige Allergy Isotope	Ventrex Laboratories, Inc.	DGC	Class II	1982-04-21
K820876	Model 3854 Electrode	Medtronic, Inc.	GXY	Class II	1982-04-21
K820860	Volumetric Pump Cassette W/attached Set	Travenol Laboratories, S.A.	FRN	Class II	1982-04-21
K820823	Multiple, Model #17	Midmark Corp	LGX	Class I	1982-04-21
K820761	Palm Beach Seating System	Pb Sales C/O Geller & Bozeman	KNN	Class I	1982-04-21
K820702	Il 7F Flow Director Thermal Dilu. Cath	Instrumentation Laboratory Co.	DYG	Class II	1982-04-21
K820661	Micro-Aire Disposable Mini & Maxi Lavag	Micro-Aire Surgical Instruments, Inc.	FQH	Class II	1982-04-21
K820615	Dacomed Snap-Gauge	Dacomed Corp.	LIL	Unclassified	1982-04-21
K820325	Stericidal	Breger Mueller West	HPX	Unclassified	1982-04-21
K820289	Anthroscopic Surgical Table	The Anspach Effort, Inc.	FWZ	Class I	1982-04-21
K820160	Hollister Wound Exudate Absorber	Hollister, Inc.	KOZ	Class I	1982-04-21
K820159	Pressure Infuser	David Clark Company, Inc.	KZD	Class I	1982-04-21
K820014	Holter ECG Scanner	Laser Scan Corp.	DPS	Class II	1982-04-21
K813224	Ceravital Ceramic Ear Canal Wall Prosth	Xomed, Inc.	ESF	Class II	1982-04-21
K820962	Cotton Swabs	Dafoe & Dafoe, Inc.	KXF	Class I	1982-04-20
K820501	Orx Dent-Aide Dental Emergency Kit	Dental Aide Products			1982-04-19
K827296	Polysonic Ultrasound Lotion	Parker Laboratories, Inc.	MUI	Class II	1982-04-16
K820973	Endoscopic Injection Needle	Mill-Rose Laboratory	FBK	Class II	1982-04-16
K820966	Disscap 110	Hospal Medical Corp.	FKQ	Class II	1982-04-16
K820965	Disscap 140	Hospal Medical Corp.	FKQ	Class II	1982-04-16
K820964	Wheelchair Pal	Pryor Products	KNO	Class I	1982-04-16
K820961	Incontinence Pad or Adult Diaper	Dafoe & Dafoe, Inc.	EYQ	Class I	1982-04-16
K820935	Model 5866-26 Lead Adapter Kit	Medtronic, Inc.	DTD	Class II	1982-04-16
K820886	Thyroxine T4 Kit	Pcl-Ria, Inc.	CDX	Class II	1982-04-16
K820880	Seralyzer Ck Reagent Strips	Miles Laboratories, Inc.	CGS	Class II	1982-04-16
K820879	Enzyme-Test Tbc T4 Uptake	Icl Scientific	KHQ	Class II	1982-04-16
K820873	Corning Certain Tm	Corning Medical & Scientific	JJS	Class I	1982-04-16
K820863	Media for in-Vitro Diagnostic Use	Isle Media and Sterile Products, Inc.	JSJ	Class I	1982-04-16
K820859	Coaxial Dual Flow Catheter	Terumo Medical Corp.	LBW	Class II	1982-04-16
K820849	Blue Ridge Rabbit Blood	Blue Ridge Media Co.	LHW	Class I	1982-04-16
K820848	Blue Ridge Sheep Blood	Blue Ridge Media Co.	LHW	Class I	1982-04-16
K820847	Isolation of Pathogenic Neisseria	Blue Ridge Media Co.	JTY	Class II	1982-04-16