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 3399 of 3526

510(k) clearances, page 3399 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791147	Arco Progammable Pacemaker System	Arco Medical Products Co.	DXY	Class III	1979-08-03
K791144	Bufferizer	Helena Laboratories, Corp.	JJN	Class I	1979-08-03
K791118	Hla Control Sera	Calbiochem-Behring Corp.	LGO	Class I	1979-08-03
K791117	Rabbit Complement	Calbiochem-Behring Corp.	KTQ	Class I	1979-08-03
K791115	Goar Anti-Human Lamboda Chain	Protos Laboratories	DEH	Class II	1979-08-03
K791110	Kinetic Determination of UV Glucose	The Dow Chemical Co.	LFR	Class II	1979-08-03
K791097	Ceptortrode with Ceptor Hesive	Med General	GXY	Class II	1979-08-03
K791096	Radioimmunoassay Test System	Corning Medical & Scientific	JMG	Class II	1979-08-03
K791076	H-H Slotted Ventricular Catheter	Holter-Hausner Intl.	JXG	Class II	1979-08-03
K791075	H-H Slotted Catheter-Reservoir	Holter-Hausner Intl.	JXG	Class II	1979-08-03
K791052	Endoscopic Instrument	Eder Instrument Co, Inc.	HET	Class II	1979-08-03
K791019	Mcspadden Condensor	Techdent, Inc.	EKR	Class I	1979-08-03
K791008	Eca (Special) Heme Buffer	Electrophoresis Corp. of America	JBD	Class II	1979-08-03
K791007	Stat Diff Stain	Bioscientific	KQC	Class I	1979-08-03
K790951	Sa/7860 Fetal Heart Monitor (Doppler)	Schlosser Alberti Co.	KNG	Class II	1979-08-03
K790950	S/a 7800 Birth Support Chair	Schlosser Alberti Co.	KNC	Class II	1979-08-03
K790935	Delton* Pit and Fissure Sealent	Johnson & Johnson Professionals, Inc.	EBC	Class II	1979-08-03
K790920	Intracranial Pressure Monitoring	Cerenovus, Inc.	GWM	Class II	1979-08-03
K790909	Ophthalmic Dressing Tray	Pent-Cal, Inc.	HOX	Class I	1979-08-03
K790878	Screening Audiometer, High Frequency	Vicon Instrument Co.	EWO	Class II	1979-08-03
K790855	Surgical Drape Clip #201	C. Intl.	GDO	Class I	1979-08-03
K790842	Subcutaneous Tissue Expander	Heyer Schulte Corp.	LCJ	Unclassified	1979-08-03
K790807	Metalit	Harry J. Bosworth Co.	EBA	Class I	1979-08-03
K790806	Porcelit	Harry J. Bosworth Co.	EBA	Class I	1979-08-03
K790774	Loda Wrist Prosthesis	Depuy, Inc.	KWM	Class II	1979-08-03
K790716	Antiserum to Human C-Reactive Proteins	Kent Laboratories, Inc.	DCN	Class II	1979-08-03
K790710	Antiserum to Human Alpha-2-Macroblobulin	Kent Laboratories, Inc.	DDY	Class II	1979-08-03
K781923	Non-Retention Enema System	Hudson Kendale Assoc., Inc.	KPL	Class II	1979-08-03
K790321	Datason Db	General Electric Co.	IYO	Class II	1979-08-01
K790220	Pacemaker Programmer	Intermedics, Inc.	KRG	Class III	1979-07-31
K791329	Fluoromatic Analyzer and Autosampler	Bio-Rad	KHO	Class I	1979-07-30
K791314	Vertebrace Spinal Supports	Vertebrace, Inc.	IPY	Class I	1979-07-30
K791309	Ucg-Lyphotest	Wampole Laboratories	JHJ	Class II	1979-07-30
K791305	Feltloc Cast Padding	Howmedica Corp.	ITG	Class I	1979-07-30
K791253	Conphar Suction Catheter-W/0 Control	Conphar, Inc.	BSY	Class I	1979-07-30
K791229	Cyber Dx 100	Cyber Diagnostics	BZM	Class II	1979-07-30
K791219	Unilith Pulse Generator	Ela Medical, Inc.	DXY	Class III	1979-07-30
K791218	Inhalation Operated Nebulizer Code	Travenol Laboratories, S.A.	CAF	Class II	1979-07-30
K791214	Tridoros 712	Siemens Corp.	IZO	Class I	1979-07-30
K791206	Hcg Ria Pregnancy Test	Hoffmann-La Roche, Inc.	JHI	Class II	1979-07-30
K791198	Bibag	Ab Medett Produkter	KNX	Class II	1979-07-30
K791197	Uridrop Special	Ab Medett Produkter	KNK	Class I	1979-07-30
K791196	Uridrop	Ab Medett Produkter	KNX	Class II	1979-07-30
K791195	Deltascan Computer Tomography X-Ray Scan	Ohio Nuclear, Inc.	JAK	Class II	1979-07-30
K791182	Acmi Rigi-Flex Nephorscope	American Cystocope Makers, Inc.	FGA	Class II	1979-07-30
K791176	3M Cold/hot Water Bag and Wrap	3M Company	FPF	Class I	1979-07-30
K791173	Surflo Injection Plug	Terumo America, Inc.	FPA	Class II	1979-07-30
K791169	Dexide Disposable Swab Stick	Dexide, Inc.	KXF	Class I	1979-07-30
K791168	Dexide Disposable Prep Stick	Dexide, Inc.	KXF	Class I	1979-07-30
K791159	Dinamap Model 855	Applied Medical Research	DXN	Class II	1979-07-30