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 2144 of 3531

510(k) clearances, page 2144 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945340	Spectacle Frames or Eyeglass Frames	Mi Mun Corp.	HQZ	Class I	1994-11-22
K945323	Spectacle Frame	M.Y. Vision Corp.	HQZ	Class I	1994-11-22
K945249	Red Dragon Corporation	J C Intl., Inc.	HQY	Class I	1994-11-22
K945124	Breast Lesion Localization Needle	Promex, Inc.	GDF	Class I	1994-11-22
K945123	Aristar Eyewear, Esprit Eyewear	Aristar Inc. U.S.A.	HQZ	Class I	1994-11-22
K945122	Aristar Eyewear, Esprit Eyewear	Aristar Inc. U.S.A.	HQY	Class I	1994-11-22
K945108	Poly Piston	Micromed Development Corp.	ETB	Class II	1994-11-22
K945107	Poly-Wire Piston	Micromed Development Corp.	ETB	Class II	1994-11-22
K945106	Micromed Total Regular and Partial Offset	Micromed Development Corp.	ETA	Class II	1994-11-22
K945104	Micromed Partial Regular and Partial Offset	Micromed Development Corp.	ETB	Class II	1994-11-22
K945039	Mci Optonix Cassette Okamoto Cassete	Mci Optonix	IXA	Class II	1994-11-22
K945036	Brighten	New Daley Intl. Trading Co.	HQY	Class I	1994-11-22
K944996	Non-Prescription Sunglasses	La Kinglong Intl., Inc.	HQY	Class I	1994-11-22
K944929	Optima Delivery Bed (Models 33901, 33903, 33902, 33905)	Merivaara Instrumentarium Corp.	FNK	Class I	1994-11-22
K944915	Axiom, Sunfast	Axiom Ent. Co., Ltd.	HQY	Class I	1994-11-22
K944910	Tomey Em-1000 Specular Microscope	Tomey Corporation USA	HJO	Class II	1994-11-22
K944797	Karl Storz Insulated Cannulae, Suction Tubes	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1994-11-22
K944726	1710 Monitoring ECG Electrode	Conmed Andover Medical, Inc.	DRX	Class II	1994-11-22
K944655	ECG Electrode	Conmed Andover Medical, Inc.	DRX	Class II	1994-11-22
K944650	Wang Bronchial Needle Brush	Mill-Rose Laboratory	EOQ	Class II	1994-11-22
K944616	Keratron Corneal Topographer	Alliance Medical Marketinig	HLQ	Class I	1994-11-22
K944491	Dermagran Hydrophilic Ointment	Derma Sciences, Inc.	KMF	Class I	1994-11-22
K944453	Quantitate Uric Acid Verifier Set	Beckman Instruments, Inc.	JJX	Class I	1994-11-22
K944402	Focometer	Lacrimedics, Inc.	HLJ	Class II	1994-11-22
K944315	Blocking Tray	Medtec LLC	IYE	Class II	1994-11-22
K944312	Shelin International Enterprises, Inc. Eyewear	Shelin International Ent., Inc.	HQY	Class I	1994-11-22
K944298	Karl Storz Insulated Scissors	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1994-11-22
K944256	Oktas Intra-Oral Dental Camera	Oktas	EIA	Class I	1994-11-22
K944080	Alt Qvet	Prisma Systems	CKA	Class I	1994-11-22
K944025	Surgical Instrument Tray	Riley Medical, Inc.	FSM	Class I	1994-11-22
K944009	Hearing Aid (Accessory)	Phoenix Management, Inc.	ESD	Class I	1994-11-22
K943628	Arthroscope	Electro Fiberoptics Corp.	HRX	Class II	1994-11-22
K943383	Imaging Workbench	Brit Systems	LMD	Class I	1994-11-22
K943357	Cemax Scanlink V	Cemax, Inc.	LMA	Class II	1994-11-22
K943192	Scimed Choice(tm) Ptca Guide Wire	Scimed Life Systems, Inc.	DQO	Class II	1994-11-22
K943158	Ad/v Imageplex(tm)	Adaptive Video, Inc.	LMD	Class I	1994-11-22
K943005	Creatinine Qvet	Prisma Systems	CGX	Class II	1994-11-22
K942998	Triglycerodes Qvet	Prisma Systems	CDT	Class I	1994-11-22
K942949	Bilirubin (Direct) Qvet	Prisma Systems	CIG	Class II	1994-11-22
K942544	Gip/medi-Globe Mechanical Lithotriptor and Baskets	Medi-Globe GmbH	LQC	Class II	1994-11-22
K942445	Synergy II	Synectics Medical, Inc.	MMZ	Class II	1994-11-22
K942413	Clarus Endoscopic Neurological Tissue Elevator	Clarus Medical Systems, Inc.	GWG	Class II	1994-11-22
K942211	Vmax229 Series Pulmonary/metabolic Systems	Sensor Medics Corp.	BTY	Class II	1994-11-22
K942180	Keeler Multilase 3000	Keeler Instruments, Inc.	HQF	Class II	1994-11-22
K942005	Gip/med-Globe Stone Extractor Baskets	Medi-Globe GmbH	LQR	Class II	1994-11-22
K941550	Automatic Corneal Shaper Surgical Instrument	Chiron Vision Corp.	HNO	Class I	1994-11-22
K941437	Unbreakable Lens	Nam Hing Plastic Factory, Ltd.	HQY	Class I	1994-11-22
K940895	Epiview	Convatec, A Bristol-Myers Squibb Co.	MGP	Unclassified	1994-11-22
K940690	Pioneer Laboratories Bone Screw	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	1994-11-22
K940671	Interspec Apogee Rx400 Ultrasound Imaging System and Doppler Ultrasound Flowmeter	Interspec, Inc.	ITX	Class II	1994-11-22