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 2171 of 3531

510(k) clearances, page 2171 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942650	Big Ben	Rud Riester GmbH & CO KG	DXN	Class II	1994-08-15
K942627	454A Electrosurgical Analyzer	Hogan & Hartson	GEI	Class II	1994-08-15
K942612	Karl Storz Wound Closure Instruments	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-08-15
K942597	Christoudias Peritoneum Twin Tissue Approximator	Holmed LLC	GCJ	Class II	1994-08-15
K941987	Heat and Moisture Exchangers and Filters	Icor AB	BYD	Class I	1994-08-15
K941841	Smartscan	Laserscope	GEX	Class II	1994-08-15
K941235	Vista B12 Assay	Syva Co.	CDD	Class II	1994-08-15
K940446	3M Model 3000 & Model 3100 Infusion Pump (Modification)	Minnesota Mining and Mfg. Co.	FRN	Class II	1994-08-15
K936269	Caspar Titanium Alloy Bone Screws	Aesculap Inc	KWQ	Class II	1994-08-15
K936000	Puritan-Bennett Cascade I Series Humidifier Modification	Medtronic, Inc.	BTT	Class II	1994-08-15
K935987	Flextrans	Baxter Diagnostics, Inc.	JSM	Class I	1994-08-15
K935137	Tefgen-Fd	American Custom Medical, Inc.	NPK	Class II	1994-08-15
K934959	Model 118 Fetal/maternal Monitor	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1994-08-15
K924010	Redinov Perfusion Set	Bipress, Inc.	FPA	Class II	1994-08-15
K943475	Ultra Hydrophilic Alginae	Essential Dental Systems, Inc.	ELW	Class II	1994-08-12
K942789	Mistassist	The Merlin Corp.	LRD	Class I	1994-08-12
K942219	Algidenco and Algiprint Impression Materials	Robert W. Bauer & Assoc., Inc.	ELW	Class II	1994-08-12
K941812	Slices	Microsignal Corp.	LNH	Class II	1994-08-12
K932041	Xanchor Suture Attachment Device	Orthopaedic Biosystems, Ltd.	JDR	Class II	1994-08-12
K943617	Disposable Manual Resuscitator	Medtronic, Inc.	BTM	Class II	1994-08-11
K943609	Sunglasses	Konwan Optical Xiamen Co., Ltd.	HQY	Class I	1994-08-11
K943568	Faconnable Eyewear (Sunglasses)	Blink Designs, Inc.	HQY	Class I	1994-08-11
K943490	Continental 45 (Hefilcon a) Spherical & Aspheric Contact Lenses	Continental Soft Lens, Inc.	LPL	Class II	1994-08-11
K941950	Opsis Thoracoscopy Video System Thoraciccam and Thoraciccam 360	Baxter Healthcare Corporation	GCJ	Class II	1994-08-11
K941343	Spinal Anesthesia Tray	Spinal Specialties, Inc.	CAZ	Class II	1994-08-11
K941197	Silk*skin Scar Treatment	Puritas Health Care, Inc.	MDA	Class I	1994-08-11
K940896	Medflator Ii(tm) Disposable Inflation Device	Medex, Inc.	MAV	Class II	1994-08-11
K940547	Flow Direct Thermodilut Balloon Cath Heparin Coated	J-Lloyd Medical, Inc.	DYG	Class II	1994-08-11
K940234	Carpal Tunnel System	Richard Wolf Medical Instruments Corp.	HRX	Class II	1994-08-11
K934368	Nk Pressure-Specified Sensory Device, Model Pssd-001	Nk Biotechnical Engineering Co.	LLN	Class I	1994-08-11
K925701	Minipack 911-Stc	Pace Tech, Inc.	CCK	Class II	1994-08-11
K921565	Cardiopulmonary Metabolic Measuement Cart	Quiton Instrument Co.	BZL	Class II	1994-08-11
K943624	Elmed Pneumoperitoneum Needles	Henke-Sass Wolf, GmbH.	FHO	Class II	1994-08-10
K943567	Faconnable Eyewear	Blink Designs, Inc.	HQZ	Class I	1994-08-10
K943487	Bio74-Pf Crown & Bridge Alloy	Jeneric/Pentron, Inc.	EJT	Class II	1994-08-10
K943326	Spectacle Frames	Buffard-La-Doye	HQZ	Class I	1994-08-10
K943170	Clearfil Liner Bond 2	Kuraray Co.	KLE	Class II	1994-08-10
K943169	Clearfil Ap-X and Liner Bond 2	Kuraray Co.	EBF	Class II	1994-08-10
K943168	Clearfil Ap-X	Kuraray Co.	EBF	Class II	1994-08-10
K943167	Clearfil New Bond	Kuraray Co.	KLE	Class II	1994-08-10
K943166	Clearfil Liner Bond System	Kuraray Co.	KLE	Class II	1994-08-10
K943165	Clearfil Photo Bond	Kuraray Co.	KLE	Class II	1994-08-10
K942666	Orthalgenat Impression Material	Dentauraum, Inc.	ELW	Class II	1994-08-10
K942486	Image Full Power Examination/minor Surgery Table	Mdt Corp., Inc.	FQO	Class I	1994-08-10
K942203	OTC Denture Cleanser	Combe, Inc.	EFT	Class I	1994-08-10
K941716	Microdontic Lens	New Image Industries, Inc.	EIA	Class I	1994-08-10
K941020	Drug Reconstitution Filter Device	Gelman Sciences, Inc.	FMF	Class II	1994-08-10
K935625	Alphadent Light Activated Orthodontic Adhesive Bonding System with Fluoride	Wallace A. Erickson & Co.	DYH	Class II	1994-08-10
K935264	Children's Sunglasses	Agglo Corp., Ltd.	HQY	Class I	1994-08-10
K934385	Minipack 3100/3000 Modification	Pace Tech, Inc.	DXN	Class II	1994-08-10