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 3394 of 3526

510(k) clearances, page 3394 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791378	Model 482-01 Bipolar Coaxial Pacing Lead	Intermedics, Inc.	DTB	Class III	1979-09-12
K791377	Model 484-01 Bipolar Coaxial Pacing Lead	Intermedics, Inc.	DTB	Class III	1979-09-12
K791372	Jelco & Kvo Catheter Placement Unit	Jelco Laboratories	JCY	Class I	1979-09-12
K791319	Miradapt* Polishing Instruments	Johnson & Johnson Professionals, Inc.	EJR	Class I	1979-09-12
K791318	Miradapt* Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1979-09-12
K791234	Model EEG-4217 Electroencephalograph	Nihon Kohden America Inc	GWQ	Class II	1979-09-12
K791233	Model EEG-4214 Electroencephalograph	Nihon Kohden America Inc	GWQ	Class II	1979-09-12
K791150	Electroencephalographs Models 7209,7213	Nihon Kohden America Inc	GWQ	Class II	1979-09-12
K790706	Antiserum to Rabbit Igg H & L Chain	Kent Laboratories, Inc.	DFH	Class II	1979-09-12
K770428	Various Surg. & Diagnostic Instru. Etc.	Holco Instrument Corp.	FSM	Class I	1979-09-12
K791678	Lithicron II 0403 Implantable Pacemaker	Medcor, Inc.	DXY	Class III	1979-09-07
K791667	Medtronic Models 69914/699Ou	Medtronic, Inc.	DTB	Class III	1979-09-07
K791653	Reusable Moist Heat Pack	Tru-Eze Mfg. Co., Inc.	IMA	Class I	1979-09-07
K791603	Gillette Cordless Whirlpool	The Gillette Company	ILJ	Class II	1979-09-07
K791539	Disposable 22Mm Adaptor	Hospitak, Inc.	BZA	Class I	1979-09-07
K791538	Disposable Aerosol T	Hospitak, Inc.	BZA	Class I	1979-09-07
K791537	Disposable Mouthpiece	Hospitak, Inc.	BYP	Class I	1979-09-07
K791536	Disposable Medication Nebulizer	Hospitak, Inc.	CAF	Class II	1979-09-07
K791504	Automatic Positive Beam Collimator	Dial-X Instruments, Inc.	KPW	Class II	1979-09-07
K791494	Vacutome Suction Unit	Concept, Inc.			1979-09-07
K791427	Catheterization Trays Foley and Urethral	Intermed, Inc.	KOD	Class II	1979-09-07
K791374	The Mtd Vara Set Casette Holder	Mtd, Inc.	KPR	Class II	1979-09-07
K791349	Systec 280 Integrated Suction System	Stryker Corp.	BTA	Class II	1979-09-07
K791323	Technion Electronic Fever Thermometer	Technicon Corp.	FLL	Class II	1979-09-07
K791265	Conphar Urinary Drainage Bag-2000Ml	Conphar, Inc.	KNX	Class II	1979-09-07
K791252	Conphar Female Catheter W/bag-Sterile	Conphar, Inc.	KNX	Class II	1979-09-07
K791244	Conphar Female Catheter-Sterile	Conphar, Inc.	KOD	Class II	1979-09-07
K791058	Antibody to Herpesvirus Hominis	Electro-Nucleonics Laboratories, Inc.	GQO	Class II	1979-09-07
K790993	Instant Hot & Cold Packs	Chase Mfg. Co.	IMD	Class I	1979-09-07
K790894	Uritron Urine Meter	Joseph F. Daniel, C.R.N.A.	FFG	Class II	1979-09-07
K791675	Kwick Kooler	Stahlex Corp.	IMD	Class I	1979-09-04
K791605	Goat Anti-Human Alpha-1-Antitrypsin	Protos Laboratories	DEM	Class II	1979-09-04
K791580	Cerebral Function Monitor 870	Applied Medical Research	OMA	Class II	1979-09-04
K791573	Jelonet Paraffin Gauze Dressings	Acme United Corp.	FRO	Unclassified	1979-09-04
K791570	Il Model End Tidal CO2 Analyzer	Instrumentation Laboratory Co.	CCK	Class II	1979-09-04
K791552	Models Ul-804 and Bl-801 Unipolar Leads	Pacesetter Systems	DTB	Class III	1979-09-04
K791540	Electrocardiograph Model ECG-5403	Nihon Kohden America Inc	DPS	Class II	1979-09-04
K791532	Sureloc External Connector	Polamedco, Inc.	BZA	Class I	1979-09-04
K791511	Enzymatic Reagent Set, 4X250 Ml.	Macomb Chemical Co.	CHH	Class I	1979-09-04
K791509	Axiom Gastro Sump Drain	Axiom Medical, Inc.			1979-09-04
K791508	Axiom Filtered Connector	Axiom Medical, Inc.			1979-09-04
K791502	Quantimune Tobramycin Ria Radioimmuno	Bio-Rad	KLB	Class II	1979-09-04
K791491	Biolite Carbon Coated Dental Implant	Carbomedics, Inc.	DZE	Class II	1979-09-04
K791479	Endo Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-09-04
K791478	Fluid Thioglycollate Medium	Isle Media and Sterile Products, Inc.	JSC	Class I	1979-09-04
K791477	Xld Agar (Xylase Lysine Desoxy Agar)	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-09-04
K791476	.E.c Medium (Escherichia Coli Medium)	Isle Media and Sterile Products, Inc.	JSF	Class I	1979-09-04
K791475	Hektoen Enteric Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-09-04
K791474	Simmons Citrate Agar	Isle Media and Sterile Products, Inc.	JSF	Class I	1979-09-04
K791417	Implantable Pulse Generator Pacemaker	Intermedics, Inc.	DXY	Class III	1979-09-04