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 2026-11-02, 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 998 of 3531

510(k) clearances, page 998 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101847	Urgent Pc Stimulator; Urgent Pc Lead Set	Uroplasty, LLC	NAM	Class II	2010-10-21
K101145	Surgilance Safety Lancets, Models Sln100, Sln200, Sln240, Sln300, Slb200, Slb250	Medipurpose Pte. Ltd.	FMK	Class II	2010-10-21
K101104	Remin Pro	Voco GmbH	EJR	Class I	2010-10-21
K101014	Bond Bone	MIS Implants Technologies Ltd.	LYC	Class II	2010-10-21
K101006	Wavelight Fs200 Laser System Model: Fs200	Alcon Laboratories	GEX	Class II	2010-10-21
K100976	T2 Xvbr 1.5 Spinal System	Medtronic Sofamor Danek USA Inc	MQP	Class II	2010-10-21
K100960	Wds X-Pod and Zen-X Digital X-Ray Sensors	Cefla S.C.	MUH	Class II	2010-10-21
K100742	Exactech Gps	Blue Ortho	OLO	Class II	2010-10-21
K100172	Tokuyama Shield Force	Tokuyama Dental Corporation	LBH	Class II	2010-10-21
K093076	Vitek 2 Gram Positive Doxcycline	bioMerieux, Inc.	LON	Class II	2010-10-21
K092641	Charmcare Tabletop Pulse Oximeter	Charmcare Co., Ltd.	DQA	Class II	2010-10-21
K102916	G-Cath Tissue Anchor Delivery Catheter	Usgi Medical	GAT	Class II	2010-10-20
K102903	Pioneer Cannulated Screw System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	2010-10-20
K102701	Viper Spine System	DePuy Spine, Inc.	NKB	Class II	2010-10-20
K102443	Intrafix Tibial Sheath	DePuy Mitek, Inc.	MBI	Class II	2010-10-20
K102441	Nano-Check Ami 2 in 1 Cardiac Marker, Ctnl and Myoglobin	Nano-Ditech Corporation	MMI	Class II	2010-10-20
K102426	Carescape Model V100 Vital Signs Monitor	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2010-10-20
K102131	Nano-Check Ami Ctni Cardiac Marker Test	Nano-Ditech Corporation	MMI	Class II	2010-10-20
K102088	Journey Inclined Platform Lift and Supra Curved Incline Platform Lift	Thyssenkrupp Ceteco SRL	ING	Class II	2010-10-20
K102031	Galaxy Lite	Future Mobility Healthcare Inc.	IOR	Class I	2010-10-20
K101936	Contours Vsp III Volar Plating System	Orthofix SRL	HRS	Class II	2010-10-20
K101843	Duramax Chronic Hemodialysis Catheter and Procedure Kit	Boston Scientific Corporation	MSD	Class II	2010-10-20
K101497	Delivery Sheath, Model Adelante Breezeway	Oscor Inc.	DYB	Class II	2010-10-20
K101309	Exelint Aluminum Hub Blunt Needles	Exelint International Co.	LHI	Class II	2010-10-20
K092571	Gyrus Acmi Biocoag Probe	Gyrus ACMI, Inc.	KNS	Class II	2010-10-20
K092256	Thera- Heat Heated Humidifier, Model Rc70000, Rc70072, Rc70075, Rc70077, Rc70012	Abbott Medical	BTT	Class II	2010-10-20
K102737	Kendall Scd 700 Sequential Compression Controller	Medtronic, Inc.	JOW	Class II	2010-10-19
K102732	Vasograd Dvt Compression Garment	Compression Therapy Concepts, Inc.	JOW	Class II	2010-10-19
K102023	Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3l60c	Shantou Institute of Ultrasonic Instruments (Siui	IYN	Class II	2010-10-19
K101417	Babylance Heel Incision Device , Models Blp50, Blp200, Bln50, Bln200	Medipurpose Pte. Ltd.	FMK	Class II	2010-10-19
K093803	Bio-Modular Reverse Sholder	Biomet Manufacturing Corp	PHX	Class II	2010-10-19
K093244	Unique Temp Warming Blankets, Model 8001140Xxx	Geratherm Medical AG	DWJ	Class II	2010-10-19
K092809	Hrv Acquire	WR Medical Electronics Co.	DRT	Class II	2010-10-19
K102721	Livewire Electophysiology Catheter	Abbott Medical	DRF	Class II	2010-10-18
K102485	Re-Trace Ureteral Access Sheath	MEDLINE INDUSTRIES, LP - Northfield	FED	Class II	2010-10-18
K102239	Carescape Monitor B650	GE Healthcare Finland Oy	MHX	Class II	2010-10-18
K101933	Modification To:expedium Spine System	DePuy Spine, Inc.	NKB	Class II	2010-10-18
K101911	Immuknow-the Cylex Immune Cellfunction Assay	Cylex, Inc.	NID	Class II	2010-10-18
K101626	Lensx Laser System	Lensx Lasers, Inc.	OOE	Class II	2010-10-18
K101597	Wavesense Diabetes Manager Model Version 1.3.4	Agamatrix	NBW	Class II	2010-10-18
K101193	Pmc Laparoscopic Instruments	Pmc Medical GmbH	GCJ	Class II	2010-10-18
K100951	Medtox Buprenorphine Test	MEDTOX Diagnostics, Inc.	DJG	Class II	2010-10-18
K093471	Karl Storz Arthropump Power Irrigation/suction Pump	Karl Storz Endoscopy-America, Inc.	HRX	Class II	2010-10-18
K093105	Visteo	Owandy Inc.	EHD	Class II	2010-10-18
K102163	Realseal Xt Sealer	Sybron Dental Specialties, Inc.	KIF	Class II	2010-10-16
K100687	Vitalograph Hand Held Spirometer, Model 2120	Vitalograph Ireland Ltd.	BZG	Class II	2010-10-16
K102920	Electronic Blood Pressure Monitor	Shenzhen Pango Electronic Co., Ltd.	DXN	Class II	2010-10-15
K102774	Vacuette Quickshield with Snappy Tude Holder	Greiner Bio-One North America, Inc.	FMI	Class II	2010-10-15
K102686	Myosure Rod Lens Scope Seals	Interlace Medical, Inc.	HIH	Class II	2010-10-15
K102672	Target Detachable Coil	Boston Scientific Corporation	HCG	Class II	2010-10-15