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 2170 of 3531

510(k) clearances, page 2170 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943737	Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire	Boston Scientific Corporation	OCY	Class II	1994-08-17
K943682	Sm-Vega, Sm-Pc, Sm-Agc, Sm-Agc-H	Starkey Laboratories, Inc.	ESD	Class I	1994-08-17
K943605	Baxter Two Gallon Sharps Disposal Containers	Baxter Healthcare Corporation	FMI	Class II	1994-08-17
K943594	Baxter One Gallon Sharps Disposal Containers	Baxter Healthcare Corporation	FMI	Class II	1994-08-17
K943504	Rsx-525Hf	Fischer Imaging Corp.	IZO	Class I	1994-08-17
K943425	Fuji Hg-M Intensifying Screen	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-08-17
K943405	Style I Wrapper Sunglasses	Plastic, Inc.	HQY	Class I	1994-08-17
K943377	Sunglasses (Non-Prescription)	Carol Wright Sales	HQY	Class I	1994-08-17
K943108	Mednext Micro-Drill	Mednext, Inc.	ERL	Class II	1994-08-17
K943068	Magneforce	Ormco Corp.	ECO	Class I	1994-08-17
K943065	Interacoustics Clinical Audiometer	Precision Acoustics Ind., Inc.	EWO	Class II	1994-08-17
K942895	Miracle Ear Model Pgm	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1994-08-17
K942894	Miracle-Ear Model Pgc	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1994-08-17
K942893	Miracle-Ear Model Pgf + Remote	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1994-08-17
K942532	2 Micron Air Eliminating Filter	Medi-Dose, Inc.	FPB	Class II	1994-08-17
K942403	Infusion Cannula	MicroSurgical Technology Inc	HMX	Class I	1994-08-17
K942388	Tas-(Various) Ultrathin Flexible Endoscope	Technology Marketing Group	EOQ	Class II	1994-08-17
K942240	Dupont Apc Blood Collection Container with Lithium Heparin	Dupont Medical Products	JKA	Class II	1994-08-17
K942235	Kyokko Green Series Intensifying Screens	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-08-17
K942190	Id100 Mobile Fluoroscopic Examining Table	Image Diagnostics, Inc.	IXQ	Class II	1994-08-17
K942175	Linear Tomographic System: Pmt 6000	Continental X-Ray Corp.	IZF	Class II	1994-08-17
K941979	Video Plus with Analytical Workstation	Camtronics, Ltd.	IZI	Class II	1994-08-17
K941960	Implantech Dorsal Columella Implant Style II	Implantech Associates Inc	FZE	Class II	1994-08-17
K941849	Provipont C&b	Ivoclar USA, Inc.	EBG	Class II	1994-08-17
K941401	Mill Rose Ercp Cannulas	Mill-Rose Lab, Inc.	GCJ	Class II	1994-08-17
K941337	Flowgun Electrocautery Probes	O.R. Concepts, Inc.	GEI	Class II	1994-08-17
K940769	Dentflex Displosable Dental Saliva Ejector	Terraflex	DYN	Class I	1994-08-17
K940550	Cook Brach Needle/radio Deliv Cath/flexi Flexicath	Cook Inc.	IWJ	Class I	1994-08-17
K940386	Kodak Automixer III Integrated, Kodak Automixer III 180 Lp	Eastman Kodak Company	IXL	Class II	1994-08-17
K940370	American Catheter E.r.c.p. Cannula	Intl. Medical, Inc.	FGE	Class II	1994-08-17
K940224	Cardio Rep Ld	Helena Laboratories, Corp.	CFE	Class II	1994-08-17
K936195	Laparoscopes	Micromedical Devices, Inc.	GCJ	Class II	1994-08-17
K935267	B-D Digital Thermometer	BD Becton Dickinson Vacutainer Systems Preanalytic	FLL	Class II	1994-08-17
K934645	Radworks	Radworks Corp.	EAP	Class II	1994-08-17
K933320	Cardiometrics Flomap and Flomod Ultrasound Instrument	Cardio Metrics, Inc.	IYO	Class II	1994-08-17
K933288	Powderfree Latex Examination Gloves	Liwe Trading	LYY	Class I	1994-08-17
K943501	Sunglasses and Sport Sunglasses	Sino-World Champion Co., Ltd.	HQY	Class I	1994-08-16
K943159	Life Clip and Life Clip Applier	Life Surgery, Inc.	FZP	Class II	1994-08-16
K942566	Imx Ultrasensistive Htsh II	Abbott Medical	JLW	Class II	1994-08-16
K942377	Transtar Pressure Transducer	Medex, Inc.	DPT	Class II	1994-08-16
K941615	Axsym Valproic Acid	Abbott Medical	LEG	Class II	1994-08-16
K941453	Check Valve Solution Set	Douglas Medical Products, Inc	FPA	Class II	1994-08-16
K941225	Univix Gold Membrane Oxygenation Module with Duroflo II Heparin Treatment	Baxter Healthcare Corporation	DTZ	Class II	1994-08-16
K940969	Sunglasses	Tzong Rong Sunglasses Mfg. Co., Ltd.	HQY	Class I	1994-08-16
K936078	Culture-Pak Collection/transport System, Modified	Medical Packaging Corporation	JSM	Class I	1994-08-16
K933755	Sensor Shield, Modification	Medical Taping Systems, Inc.	DQA	Class II	1994-08-16
K932337	Culture-Pak Collection and Transport System	Medical Packaging Corporation	JSM	Class I	1994-08-16
K943656	Alpha Solar System Tanning Bed	Heartland Tan Systems	LEJ	Class II	1994-08-15
K943263	Nil	Sing Wah International Enterprises, Ltd.	HQY	Class I	1994-08-15
K942887	Model M1310a, Series 50T Fetal Telemetry System	Hewlett-Packard Co.	HGM	Class II	1994-08-15