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 3444 of 3526

510(k) clearances, page 3444 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780999	X-Ray Frame Holder	Great Eastern Lumber Co., Inc.	IZL	Class II	1978-06-27
K780969	Gamma Camera	Machlett Laboratories, Inc.	IYX	Class I	1978-06-27
K780963	X-Ray System	General X-Ray, Inc.	KPQ	Class II	1978-06-27
K780876	Ultrasonic Imager	Air-Shields, Inc.	HEM	Class II	1978-06-27
K780995	Computerized Axial Tomography	Emi Medical, Inc.	IZF	Class II	1978-06-22
K780982	Kits, Ria, Myoglobin, Human, Measurement	Cis Radiopharmaceuticals, Inc.	DDR	Class II	1978-06-22
K780978	Single Use Active Electrode Handle	Aspen Laboratories, Inc.	GEI	Class II	1978-06-22
K780977	Single Use Blade Electrode	Aspen Laboratories, Inc.	GEI	Class II	1978-06-22
K780976	Single Use Ball Electrode	Aspen Laboratories, Inc.	GEI	Class II	1978-06-22
K780975	Single Use Needle Electrode	Aspen Laboratories, Inc.	GEI	Class II	1978-06-22
K780971	Clinical Acquisition Module	Analytical Development Assoc. Corp.	IYX	Class I	1978-06-22
K780967	Lee-Alloy	Lee Pharmaceuticals	EJJ	Class II	1978-06-22
K780965	New Restodent	Lee Pharmaceuticals	EBF	Class II	1978-06-22
K780956	Otological Ventilation Tubes	Mcghan Medical Corp.	ETD	Class II	1978-06-22
K780955	Scissors, Hook, Electrosurgical	Kli	KNF	Class II	1978-06-22
K780954	Scissors, Hook, Electrosurgical	Kli	KNF	Class II	1978-06-22
K780948	System, Planning, Treatment	Emi Therapy Systems, Inc.	IWB	Class II	1978-06-22
K780947	510 Bedside X-Ray System	Union Carbide Corp.	IZL	Class II	1978-06-22
K780936	Phonic Ear	Hc Electronics	EPF	Class II	1978-06-22
K780925	Eb-Vca, Test, Antibody, Fluorescent	Litton Bionetics	JRY	Class I	1978-06-22
K780924	Electrosurgical Grounding Pad Cable	Johnson & Johnson Professionals, Inc.	GEI	Class II	1978-06-22
K780913	Additional Reagents Kits for Imm. System	Beckman Instruments, Inc.	DCF	Class II	1978-06-22
K780907	Mic-2000	Gibco Laboratories Life Technologies, Inc.	JSF	Class I	1978-06-22
K780904	Knee, Total, Femoral & Tibial	Depuy, Inc.	MBV	Class II	1978-06-22
K780887	Improved Disposable Hypodermic Needle	Pharmaseal Div., Baxter Healthcare Corp.	GAA	Class I	1978-06-22
K780881	Emit Clinical Processor - Cp 5000	Syva Co.	JQP	Class I	1978-06-22
K780870	Ria System for Human F-S Hormone	Calbiochem-Behring Corp.	CGJ	Class I	1978-06-22
K780858	Princeton Biomedix Hexokinase, Glucose	BD Becton Dickinson Vacutainer Systems Preanalytic	CFR	Class II	1978-06-22
K780835	Arantrol	Aranco Diagnostic Laboratories, Inc.	JPK	Class II	1978-06-22
K780829	Sysing and Hemoglobin Reagent	Harleco	GKR	Class II	1978-06-22
K780818	Laparotomy Sponge	Qualtex, Inc.	EFQ	Unclassified	1978-06-22
K780811	Dental Abrasive Device	Cavitron Corp.	EHL	Class I	1978-06-22
K780808	Piezomatic Ultrasonic Scaler (System S)	Dental Ventures of America, Inc.	ELC	Class II	1978-06-22
K780806	Laporotomy Sponge	Abco Dealers, Inc.	EFQ	Unclassified	1978-06-22
K780796	Zytron	Premier Dental Products Co	EBF	Class II	1978-06-22
K780790	Idi 200 Gamma Counter	Iso-Data, Inc.	JJJ	Class I	1978-06-22
K780788	Irrigation Catheter	Shiley, Inc.	GBX	Class I	1978-06-22
K780773	Prosthesis, Hip, Cathcart, Schiller Mod.	Depuy, Inc.	JDG	Class II	1978-06-22
K780734	Anticonvulsants II Calibrator Kit	Vitek Systems, Inc.	DIY	Class II	1978-06-22
K780733	Anticonvulsants III Calibrator Kit	Vitek Systems, Inc.	DKH	Class II	1978-06-22
K780695	Auto Suture Disposable Stapling Instru.	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1978-06-22
K780682	Single Patient Systems	Extracorporeal Medical Specialities, Inc.	FKP	Class II	1978-06-22
K780607	Mask, Surgeons	Abco Dealers, Inc.	FXX	Class II	1978-06-22
K780582	Detector, Bubble & Foam	Hospal Medical Corp.	FJF	Class II	1978-06-22
K780539	Stimulator Model 8021	Life-Tech Instruments, Inc.	GWF	Class II	1978-06-22
K780447	Uric Acid Reference Sera	Macomb Chemical Co.	JIT	Class II	1978-06-22
K780452	Thera-Pak	Hydro-Med Products, Inc.	ILO	Class II	1978-06-21
K780942	Blood Pump Model 7000	3M Health Care, Sarns	DWB	Class II	1978-06-19
K780935	Grab Bar	Orthopedic Equipment Co., Inc.	IKX	Class I	1978-06-19
K780908	Self-Retaining Electrode Ser. #4000-100	Andover Medical, Inc.	DRX	Class II	1978-06-19