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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1481 of 3531

510(k) clearances, page 1481 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023780	Dri Primidone Calibrators	Microgenics Corporation	DLJ	Class II	2003-02-10
K023766	Acon Strep a Twist Test Device	Acon Laboratories, Inc.	GTY	Class I	2003-02-10
K022856	Bovie Ids-300 High Frequency Electrosurgical Generator	Apyx Medical Corporation	GEI	Class II	2003-02-10
K021153	Goldway Digital Video Colposcope Imaging System, Model #Slc-2000	Goldway (Us), Inc.	HEX	Class II	2003-02-10
K030255	Silicone Dual Lumen Radpicc Catheters	C.R. Bard Inc	LJS	Class II	2003-02-07
K030126	Npac Multi-Use Ear Thermometer, Models Td 600,610,620,630,602,612,622,632, Tn 600,610,620,630,602,612,622,632, Ts 600,6	Norm Pacific Automation Corp.	FLL	Class II	2003-02-07
K030111	Diamondcoat Ultrasonic Inserts	Dentsply International, Inc.	ELC	Class II	2003-02-07
K024194	One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems	Lifescan, Inc.	NBW	Class II	2003-02-07
K023890	Prepare Cartridge	Appro Healthcare, Inc.	MRZ	Class II	2003-02-07
K023868	Dan Kerrison Rongeurs, Models K1 + Billy 1	Dannoritzer Medical Instruments	HAE	Class II	2003-02-07
K023863	Automed 3000 Infusion Pump	Help Technologies	FRN	Class II	2003-02-07
K023783	Sohniks	Sohniks Endoscopy, Inc.	HRX	Class II	2003-02-07
K023752	Bd Integra Syringe	BD	FMF	Class II	2003-02-07
K023494	Nellcor Indgo Manual Resuscitator	Medtronic, Inc.	BTM	Class II	2003-02-07
K022816	W & H Lisa Steam Sterilizer	A-dec, Inc.	FLE	Class II	2003-02-07
K022696	Teh Lin Powered Wheelchair, Model Mdg-201	Teh Lin Prosthetic & Orthopaedic, Inc.	ITI	Class II	2003-02-07
K030223	Sonocalc	Sonometric Health, LLC	LLZ	Class II	2003-02-06
K030124	Olympus Ferritin Reagent	OLYMPUS Corporation of the Americas	DBF	Class II	2003-02-06
K030123	Bioarc Sp Sling Kit	American Medical Systems, Inc.	OTN	Class II	2003-02-06
K024233	Kompressor Screw System	Kinetikos Medical, Inc.	HWC	Class II	2003-02-06
K024167	Step-Saver Stairway Chairlift	Services Industriels Savaria, Inc.	ILK	Class II	2003-02-06
K024151	El-Ana Profiles: Anti-Ribosomal Protein P	Theratest Laboratories, Inc.	MQA	Class II	2003-02-06
K024046	Tescera Glazing Resin, Model T-1804, Biscover Xt, Model G-93220P	Bisco Inc	EBD	Class II	2003-02-06
K024031	The Theratest El-Ana Profiles: Anti-Centromere	Theratest Laboratories, Inc.	LJM	Class II	2003-02-06
K023771	Synamps2	Neuroscan	GWQ	Class II	2003-02-06
K023593	Seraquest Anti-Thyroid Peroxidase (Tpo)	Quest Intl., Inc.	JZO	Class II	2003-02-06
K021271	Electro-Nerve Stimulator TENS Model Bmls02-3	BioMedical Life Systems Inc.	GZJ	Class II	2003-02-06
K021270	Electro-Nerve Stimulator TENS Model Bmls02-2	BioMedical Life Systems Inc.	GZJ	Class II	2003-02-06
K020885	Fassire-Duval Telescopic Im System	Orthopediatrics Canada ULC	HSB	Class II	2003-02-06
K030122	Depuy Summit Basic Press-Fit Hip Stem	Depuy Orthopaedics Inc.	LWJ	Class II	2003-02-05
K030103	Summit Oct Spinal System Minipolyaxial Screws	Depuyacromed	MNI	Class II	2003-02-05
K030085	Cardius-1 and Cardis-2	Digirad Corp.	KPS	Class II	2003-02-05
K030079	Versys Beaded Fullcoat Bowed Revision Hip Prosthesis	Zimmer GmbH	LPH	Class II	2003-02-05
K030060	Spinemed	Cert Health Sciences, LLC	ITH	Class II	2003-02-05
K030048	Ha Pmi Femoral Hip Stem	Biomet Orthopedics, Inc.	LPH	Class II	2003-02-05
K030037	Universal Total Wrist System	Kinetikos Medical, Inc.	JWJ	Class II	2003-02-05
K024279	Ness Children System	Ness-Neuromuscular Electrical Stimulation Systems	IPG	Class I	2003-02-05
K024003	Gelflex Delta Soft Contact Lens Material Methafilcon a 55% Water Content Clear or Blue Visitint, Gelflex Alpha Soft Cont	Gelflex	LPL	Class II	2003-02-05
K023994	Oria Spinal Clip System, Types Bd and Bj	Ortho Tec, LLC	MNH	Class II	2003-02-05
K023946	Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device	Acon Laboratories, Inc.	DIS	Class II	2003-02-05
K023921	Jet-X Ha Coated Half Pins	Smith & Nephew, Inc.	JDW	Class II	2003-02-05
K023879	Small Titanium Wrist Fusion Plate	Synthes (USA) Products LLC	HRS	Class II	2003-02-05
K023799	Frios Algipore	Friadent GmbH	LYC	Class II	2003-02-05
K022959	Safestep Safety Dental Cartridge Injector, Model 33-00000-1	MDC Research, Ltd.	EJI	Class II	2003-02-05
K022877	Observer Ultrasound Reporting and Imaging System	Vision Chips, Inc.	LLZ	Class II	2003-02-05
K021654	Reprocessed Compression Sleeve	Alliance Medical Corp.	JOW	Class II	2003-02-05
K024188	Up-Df500 Filmstation Digital Film Imager	Sony Medical Systems	LMC	Class II	2003-02-04
K024187	Spirit III Totalsense Cardiac Coil	GE Healthcare Coils	MOS	Class II	2003-02-04
K024066	Infinion Software Features	Philips North America LLC	LNH	Class II	2003-02-04
K024042	Panorama Enhancements	Philips North America LLC	LNH	Class II	2003-02-04