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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2802 of 3530

510(k) clearances, page 2802 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871774	Ccs-Xxx, Cardioplegia Administration Sets	Gish Biomedical, Inc.	DTR	Class II	1987-08-03
K871441	Electrode Rte-3, Clip-on Diagnostic Electrode	Nitto Denko America, Inc.	DRX	Class II	1987-08-03
K870859	Bag-Tail Bleed Valve	Dryden Corp.	CAI	Class I	1987-08-03
K872897	Tsh Serozyme Immunoenzymetric Kit, Mag. Solid Pha.	Serono Diagnostics, Inc.	JLW	Class II	1987-07-31
K872868	Aspen Esmark Bandage	Aspen Laboratories, Inc.	FQM	Class I	1987-07-31
K872792	Waters M600e Multi-Solvent Delivery System	EMD Millipore Corporation			1987-07-31
K872758	Theatre Gowns	Smith & Nephew, Inc.	FYA	Class II	1987-07-31
K872716	Ciba Corning Model 580 Alliance I.s.e. Module	Ciba Corning Diagnostics Corp.	JGS	Class II	1987-07-31
K872620	Solos Eyesite Drapes	Solos Ophthalmology	HMT	Class II	1987-07-31
K872612	Solos Eyesite Sponges	Solos Ophthalmology	HOZ	Class II	1987-07-31
K872610	Solos Eyesite Cannulas	Solos Ophthalmology	HMX	Class I	1987-07-31
K872592	Imack-Mb(tm)	Intl. Immunoassay Laboratories, Inc.	JHT	Class II	1987-07-31
K872551	Seamed Model 3200	Seamed Corp.	DTE	Class II	1987-07-31
K872374	Widex Hearing Aid Model Es1	Widex Hearing Aid Co., Inc.	ESD	Class I	1987-07-31
K872372	Behind-the-Ear Hearing Aid Oticon E40	Oticon, Inc.	ESD	Class I	1987-07-31
K872348	Hearing Aid	Assured Sound Laboratories, Inc.	ESD	Class I	1987-07-31
K872309	Micromedic Combostat Lh/fsh Kit	Micromedic Systems	CGJ	Class I	1987-07-31
K872217	Thromboscreen Joshua Hemoglobin S Screening Kit	Pacific Hemostasis	GHM	Class II	1987-07-31
K872196	Aqueous Blood Gas/electrolyte Contr Lev i,ii & III	American Dade	JJS	Class I	1987-07-31
K872098	Cremeen Alveolar Bone Caliper	Bowen & Company, Inc.	EIL	Class I	1987-07-31
K872091	Currettes, Alveolar (Molt and Miller)	Military Engineering, Inc.	EMS	Class I	1987-07-31
K872082	Respiratory Syncytial Virus Control Slide	Medical Diagnostic Technologies, Inc.	LKT	Class I	1987-07-31
K872028	Birdie Bracket	William W. Wilkerson & Gregory A. Knutson	ISA	Class I	1987-07-31
K871955	Temporary Screw	Implant Innovations International, Inc.	DZE	Class II	1987-07-31
K871954	Abutment Head Post	Implant Innovations International, Inc.	DZE	Class II	1987-07-31
K871953	Temporary Bridge Head	Implant Innovations International, Inc.	DZE	Class II	1987-07-31
K871929	Probright Tooth Polisher	Lap Investments, Inc.	JEQ	Class I	1987-07-31
K871887	Anchor Iia/2 Stage Osseo. Tit. 6/4 Alloy Implant	Anchor Implants, Ltd.	DZE	Class II	1987-07-31
K871834	Drill, Hand, Bone, Smedberg	Military Engineering, Inc.	DZJ	Class II	1987-07-31
K871746	Captia(r) Toxo-M: an Enzyme Immunoassay	Mercia Diagnostics, Ltd.	LGD	Class II	1987-07-31
K871146	Gustilo/rand Total Knee System (Genesis)	Richards Medical Co., Inc.	JWH	Class II	1987-07-31
K870995	Scalp Vein Set	Mac Lee Medical Products	FPA	Class II	1987-07-31
K872739	Safe-Seat, Low-Profile Wheelchair Cushion	D.A. Schulman, Inc.	KIC	Class I	1987-07-30
K872738	Cortical Bone Screws	Military Engineering, Inc.	HWC	Class II	1987-07-30
K871905	Toxoplasma Gondii Igg Elisa	Electro-Nucleonics Laboratories, Inc.	LGD	Class II	1987-07-30
K871795	Rapid Diagnostic System for Mycobacterium Tuber.	Hologic, Inc.	LQF	Class I	1987-07-30
K870817	Mediport II Model Mp-Dl Vascular Access Port	C.R. Bard Inc	LJT	Class II	1987-07-30
K872624	Intrasite Interactive Hydrocolloid Wound Dressing	Smith & Nephew, Inc.	FRO	Unclassified	1987-07-29
K872398	t.e.n.s. Device Model Spl 2000	Spartan Laboratories, Inc.	GZJ	Class II	1987-07-29
K872229	Vitel III, ECG Transmitter	Equimed Corp.	DSH	Class II	1987-07-29
K872189	Methanol, Absolute	Remel Inc	JTS	Class I	1987-07-29
K872187	Tb Kinyoun Carbolfuchsin	Remel Inc	JTS	Class I	1987-07-29
K872186	Sulfuric Acid 10%	Remel Inc	JTS	Class I	1987-07-29
K872185	Light Green	Remel Inc	JTS	Class I	1987-07-29
K872184	Tb Methylene Blue	Remel Inc	JTS	Class I	1987-07-29
K872144	Modified Digital Blood Pressure/pulse Meter	Vestra-Subco, Inc.	DXQ	Class II	1987-07-29
K871886	Modified Sphygmomed Non-Invasive Blood Pres. Monit	Draeger, Inc.	DXN	Class II	1987-07-29
K871720	Modified Model Ua-731 Digital Sphygmomanometer	A and D Engineering, Inc.	DSK	Class II	1987-07-29
K871418	Vitalnet(tm) System (Dinamap(tm), Model 2200)	Critikon Company, LLC	DXN	Class II	1987-07-29
K872757	Opsite Speciality Drapes	Smith & Nephew, Inc.	KKX	Class II	1987-07-28