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 2026-10-12, 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 3320 of 3528

510(k) clearances, page 3320 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K803101	Prebypass Filter Cat.#k-5	Delta Medical Industries	KRJ	Class II	1980-12-22
K803097	Digoxin & Phenytoin Control Sera	Amersham Corp.	DIF	Class I	1980-12-22
K803092	Mic-Bioplate Inoculator	Pasco Laboratories, Inc.	JQW	Class I	1980-12-22
K803082	Adhesive Peristomal Covering W/wo Conn.	Johnson & Johnson Professionals, Inc.	EXB	Class I	1980-12-22
K803080	All Pupose Urethral Catheter	American Hospital Supply	KOD	Class II	1980-12-22
K803079	Foley Catheter	American Hospital Supply	KOD	Class II	1980-12-22
K803075	Digoxin Riabead Diagnostic Kit	Abbott Medical	DON	Class II	1980-12-22
K803069	Shell Kraton Thermo-Plastic Rubber Comp.	Warren E. Collins, Inc.	BYP	Class I	1980-12-22
K803063	Strap Ease 400	Independent Transfer Equipment Co.	ILK	Class II	1980-12-22
K803060	Folate 125I Radioimmunoassay	Corning Medical & Scientific	CGN	Class II	1980-12-22
K803059	Intersept* Venous Reservoir Bag & Holder	Extracorporeal Medical Specialities, Inc.	DTN	Class II	1980-12-22
K803054	Saf Fixative	Remel Co.	IGB	Class I	1980-12-22
K803053	Apexline of Pulmonary Funct. Instrum.	Warren E. Collins, Inc.	BTY	Class II	1980-12-22
K803048	Vance Urostomy Appliance	Vance Products, Inc.	EXB	Class I	1980-12-22
K803047	I-125 Labeled Digoxin	Pcl-Ria, Inc.	LCS	Class II	1980-12-22
K803045	Immu-Trace Digoxin (125I) Radioimmun.	American Dade	DOG	Class II	1980-12-22
K803042	Siemens-Elema Endocardial Lead 402S	Siemens Elema AB	DTB	Class III	1980-12-22
K803039	Profile Anti-Convul. Set Assayed S. Ctl.	General Diagnostics	DIF	Class I	1980-12-22
K803036	Profile Cardiac Set Assayed Serum Contr.	General Diagnostics	DIF	Class I	1980-12-22
K803035	Microthin-Pii Bipolar Pulse Gen. #0621	Cardiac Pacemakers, Inc.	DXY	Class III	1980-12-22
K803034	Microthin-Pii Bipolar Pulse Gen. #0623	Cardiac Pacemakers, Inc.	DXY	Class III	1980-12-22
K803033	Crusader Hyperextension Brace	Orthomedics	IPY	Class I	1980-12-22
K803030	The Bio-Tek Chromoscan	Bio-Tek Instruments, Inc.	JJQ	Class I	1980-12-22
K803029	Tlc Support Products	Mizuho Orthopedic Systems Inc			1980-12-22
K803027	Cdc Anaerobe Bl Agar W/phenylethyl Etc.	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1980-12-22
K803026	Peptone Yeast Extract Glucose Broth	BD Becton Dickinson Vacutainer Systems Preanalytic	JSC	Class I	1980-12-22
K803025	Cdc Anaerobe Blood Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSG	Class I	1980-12-22
K803024	Cdc Anaerobe Laked Bl Agar W/paramomy.	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1980-12-22
K803023	Enriched Thioglycollate Medium	BD Becton Dickinson Vacutainer Systems Preanalytic	JSG	Class I	1980-12-22
K803022	Cdc Anaerobe Bld Agar W/kanamycin Etc.	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1980-12-22
K803019	Seralyzer Ldh Reagent Strips, Calibr	Miles Laboratories, Inc.	CFJ	Class II	1980-12-22
K803014	Sensomat	Biochem International, Inc.	CBZ	Class II	1980-12-22
K803004	Amino Acid Analyser System	Lkb Instruments, Inc.	JJF	Class I	1980-12-22
K803002	Elecath Fluid-Drain Assembly	Electro-Catheter Corp.	DQR	Class II	1980-12-22
K802999	Beta-Tec Qualitative	Armkel, LLC	JHI	Class II	1980-12-22
K802998	Patient Care Disposable Infant Shirts	American Convertors Div., American Pharmaseal	KME	Class I	1980-12-22
K802997	Hdl-Cholesterol Control Serum	Isolab, Inc.	JJX	Class I	1980-12-22
K802995	Trypticase Soy Agar W/5% Sheep Bld. Cell	Sacks Farms Biological Products	JSH	Class I	1980-12-22
K802994	Trypticase Soy Agar W/5% Rabbit Bld. Cel	Sacks Farms Biological Products	JSH	Class I	1980-12-22
K802986	Powered Wheelchair	Vessa, Ltd.	ITI	Class II	1980-12-22
K802968	Unipolar Endocardial Laser Drilled Elec	Telectronics, Inc.	DTB	Class III	1980-12-22
K802962	Chem-Assay Standard-Controls	National Bio-Technical Laboratories	JJY	Class I	1980-12-22
K802957	Mueller Hinton Broth	Gibco Laboratories Life Technologies, Inc.	JTZ	Class II	1980-12-22
K802956	Gambro a-V Fistula Needle Set	Gambro, Inc.	FIE	Class II	1980-12-22
K802947	Oricult Dtm	Orion Diagnostica, Inc.	JSI	Class I	1980-12-22
K802946	Mycology Culture System	Orion Diagnostica, Inc.	JSJ	Class I	1980-12-22
K802944	Quantimune E3 Ria	Bio-Rad	CGI	Class I	1980-12-22
K802912	Helena at-III Quiplate Procedure	Helena Laboratories, Corp.	JBQ	Class II	1980-12-22
K802910	Plastic Fracture Cast Brace Knee Joint	Orthomedics	IQI	Class I	1980-12-22
K802895	Cobe Centry 2 Variable Concentrate-18-	Cobe Laboratories, Inc.	KDC	Class I	1980-12-22