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 2175 of 3531

510(k) clearances, page 2175 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942231	Microview Ii/microrail II Catheters	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1994-08-01
K940735	Liquid Amylase (Cnpg3) Reagent Set	Horiba Instruments Incorporated	CIJ	Class II	1994-08-01
K940620	Rossmax International Limited Accuracy Blood Pressure Monitor	Quality Systems Design, Inc.	DXN	Class II	1994-08-01
K940425	Imagyn Medical Inflation Device with Non-Invasive Pressure Tubing	Imagyn Medical, Inc.	MAV	Class II	1994-08-01
K936233	Pelvic Radius Plate	Smith & Nephew Richards, Inc.	HRS	Class II	1994-08-01
K936221	Probe Tip/peri Probe/peri Probe Comp.	Pd International AB	EIX	Class I	1994-08-01
K936151	Extraoral Headgear	Dentauraum, Inc.	DZB	Class II	1994-08-01
K935782	Dtx and Dtx Plus Disposable Pressure Transducers and Accessories	GE Healthcare	DXN	Class II	1994-08-01
K935691	Model Gp-252 General Purpose Coil	Diagnostic Instrument Corp.	LNH	Class II	1994-08-01
K935477	As/3(tm) Anesthesia Monitor Syst Interface Board	Datex Division Instrumentarium Corp.	CCK	Class II	1994-08-01
K935315	Maytex Powder-Free Latex Examination Gloves	Maytex Corp	LYY	Class I	1994-08-01
K935314	Maytex Latex Examination Gloves, Powdered	Maytex Corp	LYY	Class I	1994-08-01
K935228	Model 644 Sweat Diluent	Ciba Corning Diagnostics Corp.	CGZ	Class II	1994-08-01
K934571	Bvr Contra-Angle Handpiece	Bvr Aero Precision Corp.	EGS	Class I	1994-08-01
K934059	Dall Miles System Grooved Button	Howmedica Corp.	JDQ	Class II	1994-08-01
K932721	Arthrotek Set Screw	Zimmer GmbH	HWC	Class II	1994-08-01
K925490	Integral III Biointegrated Dental Implant System	Calcitek, Inc.	DZE	Class II	1994-08-01
K943368	Tru-Core Needle Set	Ideamatrix	KNW	Class II	1994-07-29
K943046	Skin Staple Removal Trays	Sterile Concepts, Inc.	MCZ	Class I	1994-07-29
K942909	Kodak Insight Twin-Load Insert	Eastman Kodak Company	EAM	Class I	1994-07-29
K942805	Kyokko Blue Series Intensifying Screens	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-07-29
K942792	Bucky Stand Br-10M	Shimadzu Corp.	KPR	Class II	1994-07-29
K942778	Model Vpw2877f8, Mammo 5 Power Supply	Varian Assoc., Inc.	IZO	Class I	1994-07-29
K942674	Angiorest Table Pad System	Scribner Browne Medical Design, Inc.	JAA	Class II	1994-07-29
K942481	Fuji Ultima Ec-Ma Cassette	FUJIFILM Healthcare Americas Corporation	IXA	Class II	1994-07-29
K942283	Comfeel Plus Transparent Dressing	Richard Hamer Assoc., Inc.	KMF	Class I	1994-07-29
K942158	Aquaplast Nasal Splints, Precut Silver Splint Patterns and Splint Kits	Anholt Technologies Inc.	EPP	Class I	1994-07-29
K942116	Snac (Siemens Nuclear Acquisition Computer)	Siemens Corp.	KPS	Class II	1994-07-29
K942092	Dpd-3	Scanditronix, Inc.	IYE	Class II	1994-07-29
K941936	Unscented Menstrual Tampon	Johnson & Johnson Worldwide	HEB	Class II	1994-07-29
K941933	Isg Medical Imaging Family of Workstations (Mifw)	I.S.G. Technologies, Inc.	LLZ	Class II	1994-07-29
K941745	Tsx-002A (Xvision) CT Scanner	Toshiba America Medical Systems, In.C	JAK	Class II	1994-07-29
K941017	F/c/w Tubestand	Acoma Medical Imaging, Inc.	IYB	Class I	1994-07-29
K941004	Cts System	Acoma Medical Imaging, Inc.	IYB	Class I	1994-07-29
K940952	Umbili-Cath-S-Dl	Gesco Intl., Inc.	FOS	Class II	1994-07-29
K940423	Nova Microsonics Access Image Management Network/access Acquisition Module	Advanced Technology Laboratories, Inc.	LMD	Class I	1994-07-29
K940378	Coverlet Adhesive Dressing	Beiersdorf, Inc.	KGX	Class I	1994-07-29
K940216	Beltone Series 100 Audiometers	Beltone Electronics Corp.	EWO	Class II	1994-07-29
K936068	Orthophos 3/ Orthophos 3C	KaVo Dental Technologies, LLC	EAP	Class II	1994-07-29
K935928	Rit 113 Film Analysis System	Radiological Imaging Technology, Inc.	IYE	Class II	1994-07-29
K935875	Osteonics Screwless Acetabular Components	Osteonics Corp.	LPH	Class II	1994-07-29
K935435	Nuclear Assoc 37-08 Ser, Raycast Hp Radio Immob Syst	Victoreen, Inc.	IYE	Class II	1994-07-29
K934513	Provider Pump Set W/infusion Cartridge	Abbott Medical	FPA	Class II	1994-07-29
K932868	Theratouch 4.7	Rich-Mar Corp.	LIH	Class II	1994-07-29
K932508	Angioct Option for CT-Twin, Helicat & Omniview	Elscint, Inc.	JAK	Class II	1994-07-29
K923727	Primus Hollow Fiber Dialyzer Mod. 1000, 1350, 2000	Medivators Inc	KDI	Class II	1994-07-29
K943172	Core Dynamics' Laparoscopic Smoke Eliminator	Core Dynamics, Inc.	GCJ	Class II	1994-07-28
K943102	High Performance Tips	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-07-28
K942616	Avl Compact 2 Ph/blood Gas Analyzer	Avl Scientific Corp.	CHL	Class II	1994-07-28
K942575	Cedia T4 Mab Assay	Microgenics Corporation	KLI	Class II	1994-07-28