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 2138 of 3531

510(k) clearances, page 2138 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942729	Lihtan 4100 Krypton	Lihtan Technologies, Inc.	GEX	Class II	1994-12-13
K942168	Wgl Endoscopic Grasper	Wilson Greatbatch Technologies, Inc.	GCJ	Class II	1994-12-13
K941978	High Pressure Tubing	Abbott Medical	DQO	Class II	1994-12-13
K941905	Model 3461 Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1994-12-13
K941904	Model A300cl Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1994-12-13
K941902	Model 3471 Clinical Refractometer	Vee Gee Scientific, Inc.	JRE	Class I	1994-12-13
K933846	Angiography Syringe Kits	Angiodynamics, Div. E-Z-Em, Inc.	DXT	Class II	1994-12-13
K932521	Powderfree Latex Examination Gloves	Top Glove Sdn. Bhd.	LYY	Class I	1994-12-13
K945522	I.d.-Zone Immunofixation Electrophoresis Controls	Beckman-Diagnostic Systems Group	DFT	Class II	1994-12-12
K944347	Puritan-Bennett Disposable Manual Resuscitator (Dmr)	Medtronic, Inc.	BTM	Class II	1994-12-12
K943900	Latex Medical Glove	Johnson & Johnson MEDICAL GmbH	LYY	Class I	1994-12-12
K943733	Flexiflo Six Enteral Nutrition Pump	Abbott Mfg., Inc.	LZH	Class II	1994-12-12
K943679	Univec Nonresusable Locking Syringe	Univec, Inc.	FMI	Class II	1994-12-12
K943353	Plexus/1000	Plexus Medical	FNM	Class II	1994-12-12
K943336	Retic Control-H Hematology Control/multiple	R & D Systems, Inc.	JPK	Class II	1994-12-12
K943335	Retic Control-M Hematology Control/multiple	R & D Systems, Inc.	JPK	Class II	1994-12-12
K943297	Ciba Corning Acs Folate Assay	Ciba Corning Diagnostics Corp.	CGN	Class II	1994-12-12
K942581	Bes - Breath Exposure Synchronizer	The Henry G. Dietz Co., Inc.	KPR	Class II	1994-12-12
K941818	Pm9000 Vac Trap	Precision Medical, Inc.	KDQ	Class II	1994-12-12
K941450	Inviro Syringe	Dr. F. Ross Sharp, Ltd.	MEG	Class II	1994-12-12
K941251	Finesse Iec/601	Utah Medical Products, Inc	HGI	Class II	1994-12-12
K940230	Endoscopic Mortons Neuroma Instruments	Instratek, Inc.	HRX	Class II	1994-12-12
K936015	Disposable Disc Filter	Medi-Dose, Inc.	FMF	Class II	1994-12-12
K933467	Prn Adapter	BD Becton Dickinson Vacutainer Systems Preanalytic	FOZ	Class II	1994-12-12
K930498	Neuromed Octrode Model Mnt-98 Neurostimulator Tran	Neuromed, Inc.	GZB	Class II	1994-12-12
K945573	Biopsy Device Accessory	Biopsys Medical, Inc.	KNW	Class II	1994-12-09
K945507	H 5100, H 5200, H 5300	Rudolf Riester GmbH & Co. KG	KZF	Class I	1994-12-09
K945483	Compas	General Electric Co.	IZI	Class II	1994-12-09
K945353	Clarit(tm)	Advanced Biomedical Methods, Inc.	JKA	Class II	1994-12-09
K945315	Document(r) Ammonia/ethanol Aqueous Control	Casco Standards	JJY	Class I	1994-12-09
K945287	Inhealth Blom-Singer Indwelling Valved Insert Accessory Device	Freudenberg Medical, LLC	EWL	Class II	1994-12-09
K945195	Abuscreen Online Propoxphene	Roche Diagnostic Systems, Inc.	JXN	Class II	1994-12-09
K945194	Abuscreen Online Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1994-12-09
K944967	Tomo-Link	GE Healthcare	IZF	Class II	1994-12-09
K944934	Polyurethane Solution 29% W/w	Knowell Therapeutic Technologies,Inc.	LBH	Class II	1994-12-09
K944808	Imx T3 Assay	bioMerieux, Inc.	CDP	Class II	1994-12-09
K944703	Thyroxine Enzyme Immunoassay	Diagnostic Reagents, Inc.	KLI	Class II	1994-12-09
K944490	Autodelfia Unconjugated Estriol (Ue3) Kit	Wallac Oy	CGI	Class I	1994-12-09
K944460	Datascope Intra-Aortic Balloon with Modified Stat Gard	Datascope Corp.	DSP	Class II	1994-12-09
K944229	Olympus Amylase Reagent	OLYMPUS Corporation of the Americas	JFJ	Class II	1994-12-09
K944213	6.2 Vitallium Alloy Cancellous Bone Screw	Howmedica Corp.	HWC	Class II	1994-12-09
K944209	Apr II Non Porous Hip Stem	Intermedics Orthopedics	LZO	Class II	1994-12-09
K944184	Synthetic Medical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1994-12-09
K944182	Powder Free Medical Glove	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1994-12-09
K944134	K6-1 Diagnostic System Version 3.1	Myo-Tronics, Inc.	KZM	Class II	1994-12-09
K943799	Version 5 Operating System Software	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-12-09
K943026	Potassium Qvet	Prisma Systems	CEJ	Class II	1994-12-09
K943004	Total Protein Qvet	Prisma Systems	CEK	Class II	1994-12-09
K943003	Calcium Qvet	Prisma Systems	CJJ	Class I	1994-12-09
K942961	Amylase Qvet	Prisma Systems	JFJ	Class II	1994-12-09