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 2260 of 3531

510(k) clearances, page 2260 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933556	Eh-270 Corneal Topographer	Visioptic, Inc.	HLQ	Class I	1993-11-02
K933546	V-Sil	Esschem, Inc.	ESD	Class I	1993-11-02
K933481	Sorin Monolyth Venous Reservoir	Sorin Biomedical, Inc.	DTN	Class II	1993-11-02
K933456	Comed Trogard(tm) Blunt Tip Trocar/sleeve	Conmedcorp	GCJ	Class II	1993-11-02
K933421	Endoscopic Instruments and Accessdories	L.A.S.E.R., Inc.	GCJ	Class II	1993-11-02
K933399	Kendall Urodynamic Catheters	Kendall Healthcare Products Co. Div.Of Tyco Health	FEN	Class II	1993-11-02
K933297	Model #510Ge1500 Liver Array Coil	Medic, Inc.	LNH	Class II	1993-11-02
K933181	Valleylab Force Gsu Handset Adapter Model #E0500	Medtronic, Inc.	GFI	Class I	1993-11-02
K932979	External Stability Pad	Louisville Laboratories, Inc.	GCJ	Class II	1993-11-02
K932657	Fibrin(ogen) Fdp Control Level 1 & Level 2	More Diagnostics Inc.	DAP	Class II	1993-11-02
K932647	Wire Reinforced Endotracheal Tube	Vitaid, Ltd.	BTR	Class II	1993-11-02
K932566	Aggro/link Control Software	Chrono-Log Corp.	JBX	Class II	1993-11-02
K932539	Doctor Down --Rescue Wrap	Three Dog Down	KME	Class I	1993-11-02
K932416	Promotional Sungalsses	Associated Premium Corp.	HQY	Class I	1993-11-02
K931990	Sunglasses	American Eye Way, Inc.	HQY	Class I	1993-11-02
K931954	Thoracoscope/laparoscope	Surgical Technologies, Inc.	GCM	Class II	1993-11-02
K931743	Burron Cardiovascular Angestat(tm)	B.Braun Medical, Inc.	DYB	Class II	1993-11-02
K931451	Glasses	Siegel Optik	HQY	Class I	1993-11-02
K931392	ECG Gating Unit	Resonex, Inc.	LNH	Class II	1993-11-02
K931184	Multi-View Processor (Mvp)	Philips North America LLC	IZI	Class II	1993-11-02
K930582	Sharplan Sharplase Lateral Nd:yag Fiber	Sharplan Lasers, Inc.	GEX	Class II	1993-11-02
K930061	Buffalo Filter Replacement Filter Bst312pf	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-02
K930040	Buffalo Filter Replacement #Blfs-101/103	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-02
K910007	Springfusor 10R	Go Medical Industries Pty., Ltd.	FRN	Class II	1993-11-02
K934297	Durable Medical Equipment Company, Standard Mechanical Wheelchair	Durable Medical Equipment, Inc.	IOR	Class I	1993-11-01
K934263	Portable Standard	Cloverleaf Cycle Co.	IOR	Class I	1993-11-01
K933597	Aqua+tfilterhme/thme/aqua+tfilterhch/thch	Arthro-Medic, Inc.	BYD	Class I	1993-11-01
K933554	Jedental Zinc Cement Improved	Jedental Co., Inc.	EMA	Class II	1993-11-01
K933543	Zoe Cement (Zinc Oxide & Eugenol Cement)	Jedental Co., Inc.	EMA	Class II	1993-11-01
K933446	Picture Archiving & Communications Systems(pacs)	Sudbury Systems, Inc.	KPS	Class II	1993-11-01
K933433	Modified Bronchoscope and Accessories	FUJIFILM Healthcare Americas Corporation	EOQ	Class II	1993-11-01
K933372	Visionlink Interfile Conversion Software	Evergreen Technologies, Inc.	KPS	Class II	1993-11-01
K933222	Audiometer Da 323	Futuremed Div. of Future Impex Corp.	EWO	Class II	1993-11-01
K930960	Access Magnetic Resonance Device Accessory	Toshiba America Mri, Inc.	LNH	Class II	1993-11-01
K930894	Multitrak-Plus	Zymed Medical Instrumentation	DSH	Class II	1993-11-01
K930634	Sur Flo Thermal Therapy Pads	Buckman Co., Inc.	ILO	Class II	1993-11-01
K922898	Cardio Perfect, Cardio Perfect Md	Cardio Control BV	LOS		1993-11-01
K933548	Els 1000	Bio-Tek Instruments, Inc.	JJE	Class I	1993-10-29
K933480	Microline Screen for Barbiturates	Drug Screening Systems, Inc.	DIS	Class II	1993-10-29
K933327	Histofreezer	Solarcare, Inc.	GEH	Class II	1993-10-29
K933256	Fan Beam Collimator	Siemens Gammasonics, Inc.	IYX	Class I	1993-10-29
K931150	Gore-Tex Micro Mesh	W. L. Gore & Associates, Inc.	FTL	Class II	1993-10-29
K930450	Buffalo Filter Replacement Filter #Bilf-100	Buffalo Filter Co., Inc.	FYD	Class II	1993-10-29
K930059	Buffalo Filter Replacement Filter #Bstm300	Buffalo Filter Co., Inc.	FYD	Class II	1993-10-29
K924452	Swan-Ganz Cco/svo2 Thermodilution Catheter	Baxter Healthcare Corporation	DYG	Class II	1993-10-29
K934046	Beckman Cholesterol Reagent	Beckman-Diagnostic Systems Group	CHH	Class I	1993-10-28
K933966	Sure-Adapt Non-Adhering Dressing	Medtrax Industries, Inc.	FRO	Unclassified	1993-10-28
K933915	Venti-Gentle-Haler(tm)	Vortran Medical Technology 1, Inc	CAF	Class II	1993-10-28
K933657	Remel Azithromlycin 15 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1993-10-28
K933593	Luminous 150 Fiberoptic Illuminator	Progressive Dynamics, Inc.	HBI	Class II	1993-10-28