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 1420 of 3531

510(k) clearances, page 1420 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031947	Bayer Clinitek Status Analyzer	Medrad, Inc.	KQO	Class I	2003-12-19
K031831	Topcon Model Bv-1000 Automated Subjective Refraction System	Topcon Healthcare, Inc.	HKO	Class I	2003-12-19
K031579	Instaread Lithium System	Akers Laboratories, Inc.	JIH	Class II	2003-12-19
K031436	Mediscope	Sometech Corporation	HEX	Class II	2003-12-19
K031373	Ixl Diabetes Management System	Insulet Corporation	LZG	Class II	2003-12-19
K031260	Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005	Abbott Medical	NBW	Class II	2003-12-19
K030713	Bay Area Hypersciences	Bay Area Hypersciences, LLC	CBF	Class II	2003-12-19
K033827	Ub 140	Rivertrail Mobility	ITI	Class II	2003-12-18
K033763	Modification to Slim Gliding Nail System	Plus Orthopedics	KTT	Class II	2003-12-18
K033746	Modified Coated Vicryl* Rapide (Polyglactin 910) Suture	Ethicon, Inc	GAM	Class II	2003-12-18
K033709	Vascular Solutions D-Stat 2 Dry Hemostatic Bandage	Vascular Solutions LLC	QSX	Unclassified	2003-12-18
K033672	Modification to Unity Network Id	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2003-12-18
K033612	Factor II (Prothrombin) G20210a Kit	Roche Diagnostics GmbH	NPR	Class II	2003-12-18
K033524	Coapt Endotine Chin 3.5 Device	Coapt Systems, Inc.	HWC	Class II	2003-12-18
K033240	Be-Mobile 3-Wheeled Electric Scooter, Model Dk S200	Tung Keng Enterprise Co., Ltd.	INI	Class II	2003-12-18
K033220	Be-Mobile 4-Wheeled Electric Scooter, Model Dk S280	Tung Keng Enterprise Co., Ltd.	INI	Class II	2003-12-18
K033206	Epw Foldable Power Wheelchair, Epw-03	EMG Technology Co., Ltd.	ITI	Class II	2003-12-18
K033161	Visu-Lock 5Mm Clip Applier	Gyrx, LLC	FZP	Class II	2003-12-18
K032980	Ami Reprocessed Multiple Clip Appliers	Stryker Sustainability Solutions	FZP	Class II	2003-12-18
K032973	Reprocessed Disposable Cutters, Staplers and Appliers	Stryker Sustainability Solutions	GDW	Class II	2003-12-18
K032029	Btg Smartest Glucose Test System	Bt Medical Co., Inc.	NBW	Class II	2003-12-18
K031804	Compress Distal Femoral Replacement	Zimmer GmbH	KRO	Class II	2003-12-18
K031711	Tango, Models, Bp1	American Bantex Corp.	ITI	Class II	2003-12-18
K031618	Comfort Various of Standing Wheelchair, Hero 2	Comfort Orthopedic Co., Ltd.	IPL	Class II	2003-12-18
K033753	Pelvic Array Coil	GE Healthcare Coils	MOS	Class II	2003-12-17
K033734	Lightcycler Instrument Version 1.2	Roche Diagnostics GmbH	JJF	Class I	2003-12-17
K033698	Contour-Flex Valve and Shunt System	Integra Neurosciences Implants S.A.	JXG	Class II	2003-12-17
K033682	Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube	Laboratorios Grifols, S.A.	LHI	Class II	2003-12-17
K033666	Hemaderm	Medafor, Inc.	QSY	Unclassified	2003-12-17
K033664	Modification to Alloclassic Zweymuller Sl Offset Femoral Stem	Centerpulse Orthopedics, Inc.	LZO	Class II	2003-12-17
K033653	Venturi Phaco Pack	Bausch & Lomb Incorporated	HQC	Class II	2003-12-17
K033637	Medical Image Digitizer, Model 2908	Array Corp.	LMA	Class II	2003-12-17
K033235	Gemini III Hybrid Tx/rx 4 Channel Head Coil	GE Healthcare Coils	MOS	Class II	2003-12-17
K033229	(Multiple Labels) Powder-Free Vinyl Examination Gloves	Bernard Technologies, Inc.	LYZ	Class I	2003-12-17
K033052	Conductive EEG Electrolyte	Compumedics USA, Inc.	GYB	Class II	2003-12-17
K033040	Phoenix Infant Radiant Warmer, Model 100Nws	International Hospital Supply Co.	FMT	Class II	2003-12-17
K032943	Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits	Stryker Corp.	KNW	Class II	2003-12-17
K032942	Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile	WRP Asia Pacific Sdn Bhd	KGO	Class I	2003-12-17
K032779	Modification to: Nucamma Rx	Is2 Research, Inc.	KPS	Class II	2003-12-17
K032358	B-Twin Bone Expander System (B-Twin Be System)	Disc-O-Tech Medical Technologies, Ltd.	HRX	Class II	2003-12-17
K031560	Bayer Rapidlab 1200 System	Medrad, Inc.	CHL	Class II	2003-12-17
K030086	Palacos R Bone Cement with Gentamicin	Zimmer GmbH	LOD	Class II	2003-12-17
DEN030005	Factor V Leiden Kit	Roche Diagnostics GmbH	NPQ	Class II	2003-12-17
K033793	Cleaner II Rotational Thrombectomy System	Rex Medical LP	MCW	Class II	2003-12-16
K033602	Insorb Absorbable Staple, Model Sp-B20	Incisive Surgical, Inc.	GDW	Class II	2003-12-16
K033551	Evolve	Reliance Orthodontic Products, Inc.	DYH	Class II	2003-12-16
K033380	Bayer Special Chemistry Calibrators	Bayer Diagnostics Corp.	JIX	Class II	2003-12-16
K033054	Harvard 1 Syringe Pump/harvard 1 with Pca Syringe Pump	Harvard Clinical Technology	MEA	Class II	2003-12-16
K032994	Gm3 Series Hv TENS, Model Gm3x3hv (Where X Is Parameter of Different Housing)	Gemore Technology Co., Ltd.	GZJ	Class II	2003-12-16
K032920	The Coeur Injector Adaptor/pressure Jacket, Model C859-6003	Coeur Medical	DXT	Class II	2003-12-16