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 2368 of 3531

510(k) clearances, page 2368 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K911419	Sensititre Aris Module	Sensititre, Ltd.	LRG	Class II	1992-07-01
K922708	Widex Model D32	Widex Hearing Aid Co., Inc.	ESD	Class I	1992-06-30
K922357	RNA Medical's Equil 55	Bionostics, Inc.	JJS	Class I	1992-06-30
K921661	Boehringer Mannheim/ Hitachi 911 Analyzer	Boehringer Mannheim Corp.	JJE	Class I	1992-06-30
K921624	Disposable Volume Vent/anesthesia Breath Circuits	Intertech Resources, Inc.	BYH	Class I	1992-06-30
K921607	Iolab Reusable Peristatic Cassette/ophthalmic Use	Chiron Vision Corp.	HQC	Class II	1992-06-30
K921365	Nutrimix Microcompounder	Abbott Medical	LHI	Class II	1992-06-30
K920800	Integrated Endoscopy System 1000	Zimmer GmbH	HRX	Class II	1992-06-30
K920746	Vfc Unit	Tilane Corp.	JAA	Class II	1992-06-30
K920640	Full Hemisphere Ring-Loc Liner	Zimmer GmbH	JDI	Class II	1992-06-30
K920639	Rx 90 Acetabular Component System	Zimmer GmbH	JDI	Class II	1992-06-30
K920539	Orwo X-Ray Film	Burkhart Roentgen Intl., Inc.	IWZ	Class I	1992-06-30
K915786	Blom-Singer Humid/fil Syst Inhealth in-Line Humid.	Freudenberg Medical, LLC	BYD	Class I	1992-06-30
K915739	#903 Silaflex II	Flents Products Co., Inc.	EWD	Unclassified	1992-06-30
K914517	Sd-200Iehl(tm)	Northgate Technologies Inc.	FFK	Class II	1992-06-30
K921710	Movit Device	John J. Navar, M.D.	BRY	Class I	1992-06-29
K921700	Tsh Enzyme Immunoassay Test Kit Cat. No. Kif4093	Medix Biotech, Inc.	JLW	Class II	1992-06-29
K921618	Coxsackie Virus B1-B6 Cf Antigens	Virion (U.S.), Inc.	GNG	Class I	1992-06-29
K921556	Mycoplasma Pneumoniae Igg/igm Antibody Test System	Medical Diagnostic Technologies, Inc.	LJZ	Class I	1992-06-29
K921465	Cat. No. 1471 (110V) & Cat. No. 1472 (220V)	Helena Laboratories, Corp.	GKP	Class II	1992-06-29
K920719	Ivos Analyzer	Hamilton Thorne Research	GKL	Class II	1992-06-29
K920288	Powered Vacuum Aspirator 1110-G-062	Stirn Industries	JCX	Class II	1992-06-29
K920287	Powered Vacuum Aspirator 1110-G-030	Stirn Industries	JCX	Class II	1992-06-29
K915761	Bivona-Colorado Voice Prosthesis	Bivona Medical Technologies	EWL	Class II	1992-06-29
K915378	Weck Trocar	Edward Weck, Inc.	HET	Class II	1992-06-29
K915351	Sherpa Guiding Catheter with Catheter Introducer	Medtronics Interventional Vascular	DQO	Class II	1992-06-29
K915328	Gel-Tac	Katecho LLC	DRO	Class II	1992-06-29
K914471	Needlecric	Ajs Medical Co., Inc.	JOH	Class II	1992-06-29
K922386	RNA Medical Tonometer	Bionostics, Inc.	LCH	Class I	1992-06-26
K921480	Osteo-Clage(tm) Cerciage Cable System	Acu Med, Inc.	JDQ	Class II	1992-06-26
K920258	Qbc Fibrinogen	BD Becton Dickinson Vacutainer Systems Preanalytic	KQJ	Class II	1992-06-26
K914945	Diagnostic Ultrasound System Type 3535, Modified	Bruel & Kjaer Industri A/S	IYO	Class II	1992-06-26
K912471	Eagle 3000 Sds	Amsco Co.	FLE	Class II	1992-06-26
K922230	Olympus Ggt Reagent	Olympus Corp.	JQB	Class I	1992-06-25
K922220	Olympus Au5200 Clinical Chemistry Analyzer	Olympus Corp.	JJE	Class I	1992-06-25
K921876	Mks Beam Outline Projector	Medical Knowledge Systems, Inc.	KPQ	Class II	1992-06-25
K921670	Acuson Image Management System	Acuson Corp.	IYO	Class II	1992-06-25
K921614	Milenia Folic Acid	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1992-06-25
K921469	Osteograf/n-700 Natural Hydroxylapatite 18-40 Mesh	Ceramed Corp.	LYC	Class II	1992-06-25
K921384	Pca Acetabular Insert II	Howmedica Corp.	JDL	Class III	1992-06-25
K921383	Precision Strata Total Hip Stem	Howmedica Corp.	JDI	Class II	1992-06-25
K921380	Laserscope's Disposable Laparostat W/ Fiber Diver	Laserscope	GEX	Class II	1992-06-25
K920789	B3000/b3000m Magnetic Resonance Imaging Scanner	Fonar Corp.	LNH	Class II	1992-06-25
K920764	Sunglasses and Eyeglass Frames	New Optic SRL	HQY	Class I	1992-06-25
K915662	Barrier Integrity Monitor	Incomed, Inc.	LDQ		1992-06-25
K913367	Models Mr410 & Mr480 Respiratory Humidifier/access	Fisher & Paykel Electronics, Ltd.	BTT	Class II	1992-06-25
K911874	Sleeptrace 2000	Areca Science Corp.	BZQ	Class II	1992-06-25
K922612	Cholestech Lipid Monitoring System, Total Choleste	Cholestech Corp.	CHH	Class I	1992-06-24
K921904	Thyroxine (Fpia) Kit	Tudor Laboratories, Inc.	KLI	Class II	1992-06-24
K921527	Statview	Image Data Corp.	LMD	Class I	1992-06-24