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 2243 of 3531

510(k) clearances, page 2243 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934465	Dic Tracheostomy Tube and Portex Blue Line	Smiths Industries Medical Systems, Inc.	BTR	Class II	1994-01-14
K931120	Coaxial Acute Catheter	Akcess Medical Products, Inc.	LFJ	Class II	1994-01-14
K930854	Solution Set with .2 Micron Filter	Douglas Medical Products, Inc	FPA	Class II	1994-01-14
K925978	Mpc-80 Transducer	Molded Products Inc	FIB	Class II	1994-01-14
K925297	Ri-Med	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1994-01-14
K920634	Splittable Sheath Introducer Set	Akcess Medical Products, Inc.	LFJ	Class II	1994-01-14
K935942	Surgical Laparotomy Sponge X-Ray Detectable	McNeil Healthcare LLC	EFQ	Unclassified	1994-01-13
K935591	Cedia Dau Multi-Level Thc Assay	Microgenics Corporation	LDJ	Class II	1994-01-13
K935366	Binaural Hearing Aid	Telex Communications, Inc.	ESD	Class I	1994-01-13
K935258	Hybrid Surgical Device Modification	Lca, Inc.	GEX	Class II	1994-01-13
K935180	Alanine Aminotransferase (Alt) Test	Em Diagnostic Systems, Inc.	CKA	Class I	1994-01-13
K934891	Amphetamines Eia Assay Modification	Diagnostic Reagents, Inc.	DKZ	Class II	1994-01-13
K934280	Phx Technologies Corp., 10 Mm Thoracoscopy Scrapper Device	Phx Technologies Corp.	GCJ	Class II	1994-01-13
K934279	Phx Technologies Corp., 5Mm, 10Mm, and 12Mm Blunt-Tipped Trocar Obturators and Matched Trocar Tubes	Phx Technologies Corp.	GCJ	Class II	1994-01-13
K932812	Ec 5R Plethysmograph	D. E. Hokanson, Inc.	JEH	Class II	1994-01-13
K932368	Uropaper Eiken 6B	Tanabe U.S.A., Inc.	JIL	Class II	1994-01-13
K931521	Powder Free Latex Examination Gloves	Pt. Abbergummi Medical	LYY	Class I	1994-01-13
K930796	Ise Calibrators for Corning 600 Series Analyzers	Alko Diagnostic Corp.	JZX	Class I	1994-01-13
K930231	Alko Calibration for Amdev Lytening Systems	Alko Diagnostic Corp.	JIX	Class II	1994-01-13
K930199	Alko Fluids Packs for Nova Analyzers	Alko Diagnostic Corp.	JIX	Class II	1994-01-13
K925464	Calibration Solutions for Use on Electrolyte Instr	Alko Diagnostic Corp.	JIX	Class II	1994-01-13
K925385	Reagents for Abbott Spectrum/epx (Electro Calibra)	Alko Diagnostic Corp.	JIX	Class II	1994-01-13
K923664	Scole 300 ECG Recorder	Scole Engineering Co.	DSH	Class II	1994-01-13
K935835	Busse Plastic Tubing Connectors and Accessories	Busse Hospital Disposables	BYX	Class I	1994-01-12
K935797	Schroeder Oral/nasal Directional Stylette	Stebar Instrument Corp.	BSR	Class I	1994-01-12
K933978	Nedbond Ejector Kerrison Rongeur	Redmond Neurotechnologies Corp.	HAE	Class II	1994-01-12
K933495	Mpm Gelpad (Hydrogel Saturated Sterile Gauze Pads)	Marketing Professionals in Medicine, Inc.	MGQ	Unclassified	1994-01-12
K925011	Nebulizer Pump, Powered Model 1180	Thomas Industries	BTI	Class II	1994-01-12
K925004	Allkare Barrier Wipe	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1994-01-12
K935463	Creatine Kinase-Mb (Ck-Mb) Reagent Set	Horiba Instruments Incorporated	CGS	Class II	1994-01-11
K935346	Cedia(r) Dau Opiate Assay	Microgenics Corporation	DJG	Class II	1994-01-11
K935138	Immulite Progesterone	Siemens Healthcare Diagnostics Inc.	JLS	Class I	1994-01-11
K935134	One Step Lh Test	Tcpi, Inc.	CEP	Class I	1994-01-11
K935081	Directdraw Superserum-Mini	Accriva Diagnostics, Inc.	JKA	Class II	1994-01-11
K935075	Spq Crp Control Level II	Incstar Corp.	DCN	Class II	1994-01-11
K934977	Model 5500 Ceas	Esa, Inc.	CDF	Class I	1994-01-11
K934966	Spq Pal Control Level II	Incstar Corp.	DDS	Class I	1994-01-11
K934892	Relief Plus One Reagent Strip Modification	Diagnostic Solutions, Inc.	CGA	Class II	1994-01-11
K934730	Karl Storz Endoscopic Cold Knife Blades	Karl Storz Endoscopy-America, Inc.	EZO	Class II	1994-01-11
K934170	Endomedix Y-Adapter	Endomedix	OCX	Class II	1994-01-11
K934146	N-Assay Tia Microalbumin	Crestat Diagnostics, Inc.	JIR	Class I	1994-01-11
K934009	Acs Powerguide Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1994-01-11
K933261	Grasping Forceps	Surgitek	FGO	Class II	1994-01-11
K933260	Helical Stone/flatwire Stone Baskets	Surgitek	FFL	Class II	1994-01-11
K933078	Beckman Alpha-1-Microglobulin (A1m) Reagent	Beckman Instruments, Inc.	MGA	Class I	1994-01-11
K932072	Jarit Surgical Instruments	Medical Device Inspection Company	HET	Class II	1994-01-11
K932021	Entree Cannula Fascia Anchors	Core Dynamics, Inc.	FBM	Class I	1994-01-11
K932020	Entree Blunt Tip Trocar and Adapter	Core Dynamics, Inc.	HET	Class II	1994-01-11
K931501	Numed Disposable Att. Numed Handle Lap. Inst.	Numed Technologies, Inc.	HET	Class II	1994-01-11
K931136	Apollo Camera	Life Sensing Instrument Company, Inc.	HET	Class II	1994-01-11