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 3201 of 3528

510(k) clearances, page 3201 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822654	Curing Light	Venture Technology, Inc.	EBZ	Class II	1982-10-04
K822652	Jain Insulating Boot Model 225B	Cook Pacemaker Corp.	DXY	Class III	1982-10-04
K822630	Monoject Plastic Hub Spinal Needle	Sherwood Medical Co.	BSP	Class II	1982-10-04
K822608	Mk 808 Series Nasal Oxygen Sampler	Instrumentation Industries, Incorporated	CCL	Class II	1982-10-04
K822590	Pressure Isolation Amplifier #9813 517	Honeywell, Inc.	DRJ	Class I	1982-10-04
K822583	Total Knee System	Richard'S Medical Equip., Inc.	MBV	Class II	1982-10-04
K822425	M-Mode Analysis System	User Resources, Inc.	DXK	Class II	1982-10-04
K822398	Ackrad Bronchitrac	Ackrad Laboratories	BSY	Class I	1982-10-04
K822363	Alta III ECG Recorder	Scole Engineering Co.	DSH	Class II	1982-10-04
K822309	Command Np	Cardiac Pacemakers, Inc.	DXY	Class III	1982-10-04
K822297	Enertrax Model 7100E	Medtronic, Inc.	DXY	Class III	1982-10-04
K822239	Coaxial Bipolar Pacing Electrode	Burditt & Calkins-Siemens-Elema	DTB	Class III	1982-10-04
K821711	Cardio Tehchanalyzer	Cardio Technology, Ltd.	DSI	Class II	1982-10-04
K822830	Medical Labs Fetal Scan #1000 W/central	Cranbury Medical Labs, Inc.	HGM	Class II	1982-09-30
K822792	Nuda-Plus Condom W/spermicidal Lubricant	Ansell, Inc.	HIS	Class II	1982-09-30
K822761	Delivery Tube Set #2226	Delta Medical Industries	FRN	Class II	1982-09-30
K822745	The Screening Tympanometer	American Electromedics Corp.	EWO	Class II	1982-09-30
K822722	Crown S Bridge Resin	Rohm and Haas Co.	EBG	Class II	1982-09-30
K822716	Universal Centrifuge	Biodynamics Corp.	JPI	Class II	1982-09-30
K822715	Platelet Centrifuge	Biodynamics Corp.	JQC	Class I	1982-09-30
K822702	V Agar	Granite Diagnostics, Inc.	JSH	Class I	1982-09-30
K822698	Glucoscan Controls	Lifescan, Inc.	JJX	Class I	1982-09-30
K822697	Glucoscan Test Strips	Lifescan, Inc.	CGA	Class II	1982-09-30
K822694	Yeast Assimilation Broth	Granite Diagnostics, Inc.	JSF	Class I	1982-09-30
K822650	Super Donut	Alimed, LLC	KME	Class I	1982-09-30
K822646	Quantaphos Acid Phosphatose Cont. Serum	Beckman Instruments, Inc.	JJT	Class I	1982-09-30
K822612	T3 Uptake Kits	Pcl-Ria, Inc.	KHQ	Class II	1982-09-30
K822601	Fixation Monitor	West Coast Optical Instruments, Inc.	HPT	Class I	1982-09-30
K822580	Auto Periometer 3000	Dicon, Inc.	HPT	Class I	1982-09-30
K822579	Bosch Star 66F-Sp Hearing Aid	Bosch Hearing Instruments, Inc.	ESD	Class I	1982-09-30
K822575	Leeco T3% Diagnostic Kit	Leeco Diagnostics, Inc.	KHQ	Class II	1982-09-30
K822535	Cidex*dialyzer Disinfecting Solution	Surgikos, Inc.	FKQ	Class II	1982-09-30
K822527	Anaerobe Pea Plate	Granite Diagnostics, Inc.	JSJ	Class I	1982-09-30
K822521	Automated Blood Cell Separator	Cryosan, Inc.	GKT	Class II	1982-09-30
K822505	Obstetrical Kit	Parr Emergency Product Sales, Inc.	HHD	Class I	1982-09-30
K822495	Le Case Hard Contact Lens Storage Case	Optikem International, Inc.	HPX	Unclassified	1982-09-30
K822484	Infection Control Towel	American Threshold Industries, Inc.	LDQ		1982-09-30
K822472	Antisera to Human Ferritin	Kent Laboratories, Inc.	DBF	Class II	1982-09-30
K822410	Boston Blood Donor Sets	The Boston Medical Group	BRZ	Class II	1982-09-30
K822409	Boston Blood Transfusion Sets	The Boston Medical Group	BRZ	Class II	1982-09-30
K822408	Boston Infusion Sets	The Boston Medical Group	FPA	Class II	1982-09-30
K822407	Boston Scalp Vein Infusion Sets	The Boston Medical Group	FPA	Class II	1982-09-30
K822406	Boston Solution Infusion Sets	The Boston Medical Group	FPA	Class II	1982-09-30
K822314	Dsl 1400	Diagnostic Systems Laboratories, Inc.	CGI	Class I	1982-09-30
K822231	Aca Urinary Protein Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	JGQ	Class II	1982-09-30
K822118	Fermcotest Creatinine Test Reagent	Fermco Biochemics, Inc.	CGX	Class II	1982-09-30
K822117	Fermcotest CO2 Reagnet	Fermco Biochemics, Inc.	JFL	Class II	1982-09-30
K828249	Model 4045 Radionuclide Calibrator	Radcal			1982-09-29
K828055	Mammomat B and Be	Siemens Medical Solutions USA, Inc.			1982-09-29
K828054	UV-a and UV-B Fluorescent Lamps	Zip Tan			1982-09-29