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 986 of 3531

510(k) clearances, page 986 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103212	Roughrider	Whirlwind Wheelchair International	IOR	Class I	2011-01-03
K103149	1.5T 16-Channel Hand-Wrist Coil	Invivo Corporation	MOS	Class II	2011-01-03
K103073	Super Chair for Kids by Orion	Future Mobility Healthcare Inc.	IOR	Class I	2011-01-03
K102285	Krystalrad (Atal8)	Medicatech USA	KPR	Class II	2011-01-03
K102284	Krystalrad 560 (Flaatz 560)	Medicatech USA	KPR	Class II	2011-01-03
K101853	Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115	Diadexus, Inc.	NOE	Class II	2011-01-03
K103668	Bnx Fine Needle Aspiration System	Boston Endoscopic Engineering	FCG	Class II	2010-12-30
K103412	Axiom Fascial Closure System	Axiom Technology Partners, LLC	OCW	Class II	2010-12-30
K103239	Irrigation System	United States Endoscopy Group, Inc.	OCX	Class II	2010-12-30
K103153	Voyager Nc Coronary Dilatation Catheter and Nc Trek Rx Coronary Dilatation Catheter	Abbott Vascular-Cardiac Therapies	LOX	Class II	2010-12-30
K103122	C-Max, C-Max U1, C-Max U1 160Kg, C-Max U2, C-Max U2 160Kg, S-Max, S-Max Aviation, S-Max Sella, S-Max Sella 160Kg	AAT Alber Antriebstechnik GmbH	ILK	Class II	2010-12-30
K102931	G-Cinch Suture Grasper	Usgi Medical	OCW	Class II	2010-12-30
K102663	AED Resectoscope	National Advanced Endoscopy Devices, Inc.	FJL	Class II	2010-12-30
K102616	Naviaid Balloon Guided Colonoscopy (Bgc) Device	Smart Medical Systems Ltd.	FDF	Class II	2010-12-30
K101450	Cantata Microcatheter	Cook Inc.	KRA	Class II	2010-12-30
K090105	Lupotek Kct	R2 Diagnostics, Inc.	GGW	Class II	2010-12-30
K103667	Sapphire St Portable Diode Laser	Den-Mat Holdings, LLC	GEX	Class II	2010-12-29
K103272	Zenius Spinal System	Medyssey Co., Ltd.	MNI	Class II	2010-12-29
K103097	Infrared Ear Thermometer	Radiant Innovation Inc.	FLL	Class II	2010-12-29
K102279	Incu I	Atom Medical Corporation	FMZ	Class II	2010-12-29
K102746	Mirage Fx	ResMed Corp	BZD	Class II	2010-12-28
K102210	Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls	Lin-Zhi International Inc	DKZ	Class II	2010-12-28
K101837	Acl Tightrope Double Bundle	Arthrex GmbH	HTY	Class II	2010-12-28
K100993	Inclusive Titanium Abutments for Astra Tech Osseospeed Implants	Prismatik Dentalcraft, Inc.	NHA	Class II	2010-12-28
K103608	I3 System-Abd Diagnostic Ultrasound	Ellex, Inc.	IYO	Class II	2010-12-27
K103583	Dc-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2010-12-27
K103359	Finesse Ultra Breast Biopsy System Driver (Blue, Pink)	C.R. Bard Inc	KNW	Class II	2010-12-27
K103357	Lifebridge	Lifebridge Medizintechnik AG	KFM	Class II	2010-12-27
K103193	Doseview 3D	Standard Imaging Inc.	IYE	Class II	2010-12-27
K102937	Osteophil Beta-Tcp	Cytophil, Inc	MQV	Class II	2010-12-27
K102835	Vital Signs Monitor	Edan Instruments, Inc.	DQA	Class II	2010-12-27
K102595	Medistim Veriqc System	Medi-Stim ASA	DPW	Class II	2010-12-27
K102572	Iyunni 3Id Suprapubic Cystostomy Tube Kit	Sainath Intellectual Properties, LLC	KNT	Class II	2010-12-27
K102408	Digital Diagnostic X-Ray System	DRGEM Corporation	KPR	Class II	2010-12-27
K101294	Pt2 Varian Proton Therapy System	Varian Medical Systems, Inc.	LHN	Class II	2010-12-27
K100932	Inclusive Mini Implant	Prismatik Dentalcraft, Inc.	DZE	Class II	2010-12-27
K103437	US Endoscopy Cytology Brush	United States Endoscopy Group, Inc.	FDX	Class II	2010-12-23
K103406	Microcool Breathable High Performance Surgical Gowns	Kimberly-Clark Corporation	FYA	Class II	2010-12-23
K103342	3.0T Metaflexcoil	NeoCoil, LLC	MOS	Class II	2010-12-23
K103303	Crosstex Surgical Earloop Mask- White, Crosstex Surgical Earloop No Fog Mask-White, No Fog Mask with Splash Visor-White	Crosstex International, Inc.	FXX	Class II	2010-12-23
K103235	Erbeflo 2 Disposable Tubing System	Erbe USA Inc	OCX	Class II	2010-12-23
K103221	Elecys Hgh Calset, Elecsys Hgh Calcheck 5	Roche Diagnostics GmbH	JIT	Class II	2010-12-23
K103049	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2010-12-23
K102910	Model Luna Manual Wheelchair	P.D.G., Inc.	IOR	Class I	2010-12-23
K102837	Hiroller Elevating Wheelchair	Permobil, AB	IPL	Class II	2010-12-23
K102819	Powder-Free Vinyl Patient Examination Gloves	Hebei Hongtai Plastic Products Co.,Ltd.	LYZ	Class I	2010-12-23
K102817	Powder-Free Vinyl Patient Examination Gloves	Hebei Hongtai Plastic Products Co.,Ltd.	LYZ	Class I	2010-12-23
K102452	Defogging and Cleaning Solution- Flo-X	Minimally Invasive Devices, LLC	OCT	Class II	2010-12-23
K102364	Nydiag 200	Interacoustics a/S	LXV	Unclassified	2010-12-23
K102134	Model La-1200 Multi-Channel Laser Therapy System	United Integrated Services Co., Ltd.	ILY	Class II	2010-12-23