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 2240 of 3531

510(k) clearances, page 2240 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932636	The Tucker Sling	Tucker Designs, Ltd.	FRP	Class I	1994-01-26
K932569	Pencil Point Spinal Needle and Tray	B. Braun of America, Inc.	BSP	Class II	1994-01-26
K931819	Carapace Suture Removal Trays	Carapace, Inc.	IRO	Class I	1994-01-26
K931758	Carapace Wound Dressing Kits & Laceration Trays	Carapace, Inc.	LRO	Class II	1994-01-26
K931733	Intermedics Orthopedics Reamers	Intermedics Orthopedics	HTP	Class I	1994-01-26
K931723	Hydro-Tred/air Powered Treadmill	Santa FE Swim Systems	BXB	Class I	1994-01-26
K931440	Calcitek Torque Wrench System	Calcitek, Inc.	DZE	Class II	1994-01-26
K931330	Dental Instruments Scaler	Minnesota Prophy Power, Inc.	EMN	Class I	1994-01-26
K931176	Bone Saw Blades	Betzler Mfg., Inc.	HWE	Class I	1994-01-26
K926427	Lariat Palate Expander	Easy Access Orthodontics, Inc.	EJF	Class I	1994-01-26
K926303	Arthrex Instruments (Wrist)	Arthrex GmbH	HRX	Class II	1994-01-26
K926262	First Mpj Continuous Passive Motion Device	Sgarlato Laboratories, Inc.	BXB	Class I	1994-01-26
K926081	Dental Light	Mdt Corp., Inc.	EAZ	Class I	1994-01-26
K925028	Forestadent Orthodontic Bands	Forestadent	EJF	Class I	1994-01-26
K924608	Hydrogel Coated Percuflex(r) Drainage Catheters	Boston Scientific Corporation	FGE	Class II	1994-01-26
K922252	Ti-Core New & Improved	Essential Dental Systems, Inc.	EBF	Class II	1994-01-26
K922251	Ti-Core-Natural	Essential Dental Systems, Inc.	EBF	Class II	1994-01-26
K922250	Flexi-Flow Cement with Titanium	Essential Dental Systems, Inc.	EMA	Class II	1994-01-26
K922249	Flexi-Flow Cement Natural	Essential Dental Systems, Inc.	EMA	Class II	1994-01-26
K920292	Various Kits and Trays	Professional Medical Products, Inc.	LRO	Class II	1994-01-26
K936136	Uroview Systems Tomography Option Software	GE Dec Medical Systems	JAA	Class II	1994-01-25
K935794	Cedia Dau 4-Drug Cutoff Calibrator	Microgenics Corporation	DKB	Class II	1994-01-25
K935792	Cedia Dau 5-Drug Calibrators	Microgenics Corporation	DKB	Class II	1994-01-25
K935760	Tec 2100 (Model Mt-Lplgd)	Medtec LLC	IWE	Class I	1994-01-25
K935558	Spectacle Frame/eyeglass Frame	Modern Optical, Ltd.	HQZ	Class I	1994-01-25
K935241	Gauze Dressing	Chak Tak (Shen Zhen) Enterprises, Ltd.	EFQ	Unclassified	1994-01-25
K935231	Tale Spin Sunshades	Equity Marketing, Inc.	HQY	Class I	1994-01-25
K935107	Spectacle Frames	Mr I'S Optical Boutique	HQZ	Class I	1994-01-25
K935070	Grasping Forceps, Biopsy Forceps, Spoon Forceps	Karl Storz Endoscopy-America, Inc.	FCL	Class I	1994-01-25
K935042	Roche Abuscreen Sample Oxidizing Reagent	Roche Diagnostic Systems, Inc.	DKZ	Class II	1994-01-25
K935036	Hepa Filtered Heat and Moisture Exchanger	Intertech Resources, Inc.	BYD	Class I	1994-01-25
K935003	Electric i/v Pole or Eivp2	Optical Micro Systems, Inc.	KYG	Class I	1994-01-25
K934888	Olympus Imagemanagersystem	Olympus Corp.	LMB	Class I	1994-01-25
K934494	Surgitel	General Scientific Corp.	HOH	Class I	1994-01-25
K934485	Hitachi Mpr-5000 & Mpr-7000 Magnetic Resonance Diagnostic Device Modification	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-01-25
K934402	Cool Kids Mirror Shades	Ja-Ru, Inc.	HQY	Class I	1994-01-25
K934197	Optikos Shami, Inc. Sunglasses	Optikos Shami, Inc.	HQY	Class I	1994-01-25
K934187	Spectacle Frames and Sunglasses	Wah Ming Optical Mfy. Ltd.	HQZ	Class I	1994-01-25
K934165	Sterile, Disposable Endo Speciemen Retrieval Bag	Phx Technologies Corp.	GCJ	Class II	1994-01-25
K934077	Phx Techologies Corp., 5Mm Sterile, Disposable Endoscopic Kittner Blunt Dissecting Instrument	Phx Technologies Corp.	GCJ	Class II	1994-01-25
K933984	Storz Fiberoptic Reverse Cutting Knife	Storz Instrument Co.	HQE	Class II	1994-01-25
K933725	Endoscopic Needle Driver	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-01-25
K933627	Phacofragmentor Tip	M. Imonti and Associates Inc.	HQC	Class II	1994-01-25
K933598	Endostar(tm) Stylet	Fiberoptic Medical Products, Inc.	BSR	Class I	1994-01-25
K933527	Modification of Anterior Segment Electrodes	Mira, Inc.	HWA	Class I	1994-01-25
K933223	Sunglasses	Rally Accessories, Inc.	HQY	Class I	1994-01-25
K933189	Spectacle Frames and Sunglasses	Eastern Breeze Intl. Co.	HQY	Class I	1994-01-25
K933025	Laporascopic Cannula Seal	Li Medical Technologies, Inc.	GCJ	Class II	1994-01-25
K932821	Apex Optical Ind. Co., Eye Wea Models	Apex Optical Ind. Co.	HQZ	Class I	1994-01-25
K932699	Arthrex Ar-8200 Shaver System	Arthrex GmbH	HWE	Class I	1994-01-25