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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2964 of 3529

510(k) clearances, page 2964 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853404	Qca Potassium Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	CEJ	Class II	1985-08-23
K853385	I.a.s.s., IV Set W/air Vent & I.a.p.s. W/o Airvent	Simplivia Healthcare Ltd.	FPA	Class II	1985-08-23
K853373	Delta Trol I & II	Electro-Nucleonics Laboratories, Inc.	JJT	Class I	1985-08-23
K853337	Trocar/cannula/sheath Set	American Edwards Laboratories	KOD	Class II	1985-08-23
K853282	Centrix Ribbon Tubes	Centrix, Inc.	EID	Class I	1985-08-23
K853255	Omnimed i.v. Solution Admin. Set	Omni Intl., Inc.	FPA	Class II	1985-08-23
K853152	Monoject Sample Capillary Plasma Sep W/lith Hepar	Sherwood Medical Co.	JKA	Class II	1985-08-23
K853095	Boehringer Laboratories Suction Intermittor	Boehringer Laboratories, LLC	GCX	Class II	1985-08-23
K852926	Dentolock II Denture Adhesive Cream	Solar Dental Co., Inc.			1985-08-23
K852190	Model 451 CO2 Surgical Laser	Coherent Medical Group	GEX	Class II	1985-08-23
K852093	Alloy 7	Williams Gold Refining Co., Inc.	EJS	Class II	1985-08-23
K851941	Unscented Menstrual Tampons	Personal Products Co.	HEB	Class II	1985-08-23
K851703	Glucostix Reagent Strips & Glucometer Reflect-Phot	Miles Laboratories, Inc.	CGA	Class II	1985-08-23
K851516	Chermel Scalp Vein Set	Cher Mel Corp.	FPA	Class II	1985-08-23
K853388	Monosticon Uni-Dot	Organon LLC	KTN	Class II	1985-08-22
K853387	Et - Extension Sets	Simplivia Healthcare Ltd.	FPA	Class II	1985-08-22
K853386	Multiset 40	Simplivia Healthcare Ltd.	BRZ	Class II	1985-08-22
K853283	Vaccess Tm 4006	Vas-Cath of Canada, Ltd.	LFJ	Class II	1985-08-22
K853261	Laser Rbp Laser(retinol Binding Protein Reagents)	Behring Diagnostics, Inc.	CZS	Class I	1985-08-22
K853197	Mic Jejunal Feeding Tube	Medical Innovations, Inc.	KNT	Class II	1985-08-22
K853176	Cannon Babysafe Nipple Shields	Medela AG	HFS	Class I	1985-08-22
K853174	Apo-Chrome Immunoassay Test Set for Apolipoprotein	Photec Diagnostics, Inc.	MSJ	Class I	1985-08-22
K853108	Model 372L Hearing Aid	Telex Communications, Inc.	ESD	Class I	1985-08-22
K853025	Image-Ige	Clinical Reference Laboratory, Inc.	DGC	Class II	1985-08-22
K852813	Ranger(ii)	Invacare GmbH	ITI	Class II	1985-08-22
K852811	Ranger-X	Invacare GmbH	ITI	Class II	1985-08-22
K852810	Rabbit	Invacare GmbH	ITI	Class II	1985-08-22
K852809	Jaguar	Inacare Corp.	ITI	Class II	1985-08-22
K852759	American Edwards Laboratories Flexiscope	American Edwards Laboratories	HRX	Class II	1985-08-22
K852585	Porous Apf/modular Femoral Component	Zimmer GmbH	JDI	Class II	1985-08-22
K852557	All Terrain Amigo	Amigo Sales, Inc.	INI	Class II	1985-08-22
K852532	Newport Media Transfer Container	Newport Bio Systems	KJA	Class I	1985-08-22
K852486	Dah/berg Model Hp Behind-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-08-22
K852453	Rionet Hearing Aid Hb-69Ht	Rion Acoustic Instruments, Inc.	ESD	Class I	1985-08-22
K852388	Mahurkar Subclavian Catheter Insertion Kit	Quinton, Inc.	DQY	Class II	1985-08-22
K852237	Legionella Immunofluorescent Antibody Test Kit	Genetic Systems Corp.	LHL	Class II	1985-08-22
K852198	Aml Proximal Porocoat Femoral Hip	Depuy, Inc.	LPH	Class II	1985-08-22
K852109	Penox Performer Wheelchair	Penox Technologies, Inc.	IOR	Class I	1985-08-22
K852051	External Male Catheter	Buffalo Medical Specialties Mfg., Inc.	KNX	Class II	1985-08-22
K851875	Kinnet	KCI USA, Inc.	INY	Class I	1985-08-22
K850482	Datascope 8.5 French Electrode Intra-Aortic Balloo	Datascope Corp.	DSP	Class II	1985-08-22
K853334	Non-Adhera Adhesive Pad 3X4	American White Cross, Inc.	NAD	Class I	1985-08-21
K853327	Jufrey Corp. Universal Dispos. Scalp Vein Infusion	Jufrey Multimed Corp.	FPA	Class II	1985-08-21
K853315	Cautery Tip Cleaning Pad	Kleen Test Products Corporation			1985-08-21
K853286	Staple Remover	I M, Inc.			1985-08-21
K853281	Easytop	Hydro-Med Products, Inc.			1985-08-21
K853188	Transfer Device	Advance Medical Designs Inc	LHI	Class II	1985-08-21
K852965	Enteral Feeding Pump	Empire Industries, Inc.	FRN	Class II	1985-08-21
K852897	Lee Bone Marrow Biopsy/aspiration Tray	Southland Instruments, Inc.	GAA	Class I	1985-08-21
K852888	Olympus Rigid Ureterorenoscope	Olympus Corp.	FGB	Class II	1985-08-21