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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2548 of 3530

510(k) clearances, page 2548 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K901476	Modified Entrapping Filter	Cadema Medical Products, Inc.	CAH	Class II	1990-05-01
K901212	Lig/tdm a, B, C	Ciba Corning Diagnostics Corp.	JJY	Class I	1990-05-01
K901161	Solar Shades(tm) Sunglasses	Blublocker LLC	HQY	Class I	1990-05-01
K900972	Radiation Protection Gloves	Infab, LLC.	IWP	Class I	1990-05-01
K900970	Radiation Protection Glasses	Infab, LLC.	KPY	Class I	1990-05-01
K900570	Surgilase Yag 100 in Orthopedic Surgery	Surgilase, Inc.	GEX	Class II	1990-05-01
K900511	I.c. Medical Adjustable Direct Coupler	I.C. Medical, Inc.	GEX	Class II	1990-05-01
K900349	Puritan Bennett Single Patient Use PEEP Adapter	Medtronic, Inc.	BTM	Class II	1990-05-01
K900299	Ats Y Adapter Code #2452	Artium Medical Corp.	CAC	Class II	1990-05-01
K900188	Advance Administration Sets (Varying Length)	Advance Medical Designs Inc	FPA	Class II	1990-05-01
K900187	Advance Contrast Media Sets (Varying Length)	Advance Medical Designs Inc	FPA	Class II	1990-05-01
K891681	Dilectron Urinary Conductivity Probe	Gyrus ACMI, Inc.	JRE	Class I	1990-05-01
K901612	Vitalmax 2000 ECG Monitor W/non-Invasive Blood-Pre	Pace Tech, Inc.	DQA	Class II	1990-04-30
K901423	Digital Image Scanner, Model Dis-1000	Lumisys, Inc.	LMA	Class II	1990-04-30
K901209	Model 90489 Pulse Oximeter Module	Spacelabs, Inc.	DQA	Class II	1990-04-30
K901051	22% Polyacrylic Acid Gel	Pulpdent Corporation	EBF	Class II	1990-04-30
K900901	Mp4000 Series II Compact Video Imager	International Imaging Electronics	LMC	Class II	1990-04-30
K900900	Mp3000 Series II Compact Video Imager	International Imaging Electronics	LMC	Class II	1990-04-30
K900899	Mp3000 Compact Video Imager	International Imaging Electronics	LMC	Class II	1990-04-30
K900896	6000 Plus Multi-Format Video Imager	International Imaging Electronics	LMC	Class II	1990-04-30
K900818	Vitek Immunodiagnostic Assay System (Vidas) Toxo.	Vitek Systems, Inc.	LGD	Class II	1990-04-30
K900638	P.f.c. Hip System Non-Porous Femoral Component	Johnson & Johnson International	KWL	Class II	1990-04-30
K900322	Co/cmd-1	Spirometrics, Inc.	CCJ	Class II	1990-04-30
K900026	Bruker R28 Whole-Body Mr Scanner	Bruker Medical Imaging, Inc.	LNH	Class II	1990-04-30
K897154	Nicolet Dbte Hearing Aid: Digital & Programmable	Nicolet Instrument Corp.	ESD	Class I	1990-04-30
K897121	Qekg Electrocardiograph	Qmed, Inc.	DPS	Class II	1990-04-30
K896995	Discretion, in the Canal Hearing Instrument	GN Danavox, Inc.	ESD	Class I	1990-04-30
K896915	Palladium Based Dental Alloy for Porcelain-Metal	Jelenko Co.	EJT	Class II	1990-04-30
K896739	Konica Kfdr-S	Konica Medical Corp.	LMA	Class II	1990-04-30
K896468	Eos Bluephase-P and Redphase-P Impression Material	Ivoclar North America, Inc.	ELW	Class II	1990-04-30
K895813	Glaucoma Mechanical Trephine	Trek Medical Products, Inc.	HQE	Class II	1990-04-30
K895580	Y-Adapter W/thouy Borst	Angeion Corp.	DYB	Class II	1990-04-30
K894098	Synthes External Fixation Bone Clip	Synthes (USA) Products LLC	JEC	Class II	1990-04-30
K890061	Model 3586 Resume Lead	Medtronic, Inc.	GZB	Class II	1990-04-30
K901629	Chem-Sleeve	Haz-Med, Inc.	KME	Class I	1990-04-27
K901351	Sears Model 9098 Ite Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1990-04-27
K901350	Sears Model 9094 Ite Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1990-04-27
K901256	Amalcap Plus	Ivoclar North America, Inc.	EJJ	Class II	1990-04-27
K901178	Amalgam Condenser	American Medical Ceramics, Inc.	EKJ	Class I	1990-04-27
K901095	Bi-Phase Set, Oral, Maxillofacial Surgery	Grimm & Norton	JEY	Class II	1990-04-27
K901094	Head Frame Kit, Oral Maxillofacial Surgery	Grimm & Norton	JEY	Class II	1990-04-27
K900061	Impla-Med Titanium, Implant Devices	Impla-Med	DZE	Class II	1990-04-27
K897143	Vera 103	Madsen North America, Inc.	LYN	Class II	1990-04-27
K901675	Apolipoprotein a-I (Apo a-I)	Sigma Chemical Co.	DEL	Class I	1990-04-26
K901637	Resubmitted Modified Rubalex	Orion Corp.	LQN	Class II	1990-04-26
K901623	Ambu Oxygen Regulator	Flotec, Inc.	CAN	Class I	1990-04-26
K901595	Nova Lite(tm) Ana Mk	Inova Diagnostics, Inc.	DHN	Class II	1990-04-26
K901542	E/lumina(tm)/allegro Lite(tm) Luminescence Measure	Source Scientific Systems, Inc.	JJQ	Class I	1990-04-26
K901384	Model 6000-21; Volume Neck Coil	Medical Advances, Inc.	LNH	Class II	1990-04-26
K901324	u.v. Sunlamp 95Uf-II	Light Sources, Inc.	FTC	Class II	1990-04-26