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 2304 of 3531

510(k) clearances, page 2304 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915514	Denta Safe Latex Examination Gloves	Dental Care Intl., Inc.	LYY	Class I	1993-05-07
K931227	Usdt Flow Immunoassay System, Model 9000	U.S. Drug Testing, Inc.	KZR	Class I	1993-05-06
K930869	Eco Toothbrush	Recycla-Dent, Inc.	EFW	Class I	1993-05-06
K930654	Stc Diagnostics Auto-Lyte Cannabinoids Eia	Solarcare Technologies Corp,Inc.	LDJ	Class II	1993-05-06
K930593	Bard William Harvey Aortic Root Cardioplegia Cannu	C.R. Bard Inc	DWF	Class II	1993-05-06
K926245	Abbott Vision Theophylline Iia	Abbott Medical	KLS	Class II	1993-05-06
K926157	Eyeglass Frame	Roi Factory Direct Frame Co.	HQZ	Class I	1993-05-06
K925373	Therex Low-Profile Port/1.0mm I.d./1.8mm O.d	Therex Corp.	LJT	Class II	1993-05-06
K925342	Medtronic Interventional Vascular Sherpa Guidewire	Medtronics Interventional Vascular	DQX	Class II	1993-05-06
K925131	Cordis 9 F Guiding Catheter	Cordis US Corp.	DQY	Class II	1993-05-06
K924413	Flowscan	Electrocaine Medical System	BZG	Class II	1993-05-06
K924205	Medtronic Bio-Medicus Bio-Console Model 550	Medtronic Bio-Medicus, Inc.	DWA	Class II	1993-05-06
K931320	Rionet Hearing Aid Hb-53W	Rion Co. Ltd. dba Rion Acoustic Device	ESD	Class I	1993-05-05
K931023	In-the-Ear Hearing Aid	Hearing Improvement	ESD	Class I	1993-05-05
K926462	Bel-Air Ventilation Tube	Exmoor Plastics Limited	ETD	Class II	1993-05-05
K926145	Nugold 2%	Jeneric/Pentron, Inc.	EJS	Class II	1993-05-05
K926037	Harpoon Suture Anchor	Zimmer GmbH	JDR	Class II	1993-05-05
K926036	Acufex Suture Retriever	Acufex Microsurgical, Inc.	GAE	Class I	1993-05-05
K926033	Vinyl Polysiloxane Impression System and Re'cord	Harry J. Bosworth Co.	ELW	Class II	1993-05-05
K925573	Acufex T-Bar	Acufex Microsurgical, Inc.	HRX	Class II	1993-05-05
K925237	Automatic Caloric Irrigation System	Ics Medical Corp.	KHH	Class I	1993-05-05
K923957	Nasal Cavity Wound Dressing	Smith & Nephew Richards, Inc.	KMF	Class I	1993-05-05
K923481	Philips Laser Disk Archive	Philips North America LLC	LMC	Class II	1993-05-05
K923405	The Herbst Appliance	Ormco Corp.	EJF	Class I	1993-05-05
K923381	Soft Tissue Expander	Acufex Microsurgical, Inc.	HWQ	Class I	1993-05-05
K921319	Neuromed Model Oca-30 Octode and Model Sca-30	Neuromed, Inc.	GZB	Class II	1993-05-05
K920969	Hydroxylapatite Infinity(r)	Dow Corning Wright	MEH	Class II	1993-05-05
K920968	Infinity(r) Collarless/microtaper Trochanteric Mod	Dow Corning Wright	LZO	Class II	1993-05-05
K920929	Poly Insert 20 Degree	Dow Corning Wright	JDL	Class III	1993-05-05
K920621	Acufex Passing Pins and Surgical Wire	Acufex Microsurgical, Inc.	HWQ	Class I	1993-05-05
K915525	Whiteside Ortholoc(r) Modular Revision Femor Comp	Dow Corning Wright	JWH	Class II	1993-05-05
K930561	Solstar Brillenmode Spectacle Frames	Solstar Produktions GmbH	HQZ	Class I	1993-05-03
K925050	Pc Teleradiology(tm)	Arizona State Radiology	LMD	Class I	1993-05-03
K924472	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1993-05-03
K923581	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1993-05-03
K931092	Endoscopic Retractor	L.A.S.E.R., Inc.	GCJ	Class II	1993-04-30
K930604	Balanced(tm) Nylon Bladder	Pymah Corp.	DXQ	Class II	1993-04-30
K925838	Telefactor D/eeg-32	Grass-Telefactor Product Group	GWQ	Class II	1993-04-30
K925543	Bld-18000 Series Heated Breathing Circuit	Bird Life Design	CAI	Class I	1993-04-30
K925346	Ep Amp, Model #901	Quinton Electrophysiology Corp.	DRR	Class II	1993-04-30
K924699	Pmp Muscle Stimulator	Preferred Medical Products, LLC	IPF	Class II	1993-04-30
K924287	710 Porous Ha Particles-Bii-Pore	Bio-Interfaces, Inc.	LYC	Class II	1993-04-30
K924099	Ufc Hip Stem Component	Implantology Corp.	JDG	Class II	1993-04-30
K922609	Itc Catheters W/ Hydromer	Interventional Therapeutics Corp.	DQY	Class II	1993-04-30
K915391	Fpc Hip Stem Component	Implantology Corp.	JDG	Class II	1993-04-30
K931337	Auto Suture Dilating Cannula	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-04-29
K930622	Amplatz Guidewires	Meadox Medicals, Div. Boston Scientific Corp.	DQX	Class II	1993-04-29
K930361	Asi Cystolase Laser Cystoscope	Advanced Surgical Intervention, Inc.	GEX	Class II	1993-04-29
K926214	Guide Wire for Laporoscopic Use	Terumo Medical Corp.	GCJ	Class II	1993-04-29
K925449	Replacement Rechargeable Battery Pack's	Portable Power Systems, Inc.	FRN	Class II	1993-04-29