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 2194 of 3531

510(k) clearances, page 2194 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941657	Bd Micro Fine, Ultra Fine, and Allergy Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1994-05-26
K941562	1Ml Luer-Lok Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1994-05-26
K940576	Patient Examination Gloves	Vijay Latex Products Private, Ltd.	LYY	Class I	1994-05-26
K940515	Poly Blades	Linvatec Corporation	HRX	Class II	1994-05-26
K940468	Feminine Maxi Pads	B.A. Wholesale, Inc.	HHD	Class I	1994-05-26
K940288	Water Pik Sensonic Plaque Removal Instrument	Teledyne Water Pik	JEQ	Class I	1994-05-26
K940175	Medsurg Sterile o.r. Towels	Medsurg Industries, Inc.	KKX	Class II	1994-05-26
K940022	Latex Patient Examination Glove	Siam Sempermed Corp., Ltd.	LYY	Class I	1994-05-26
K935324	Therapeutic Ultrasound and Stimulator	Chattanooga Group, Inc.	GZJ	Class II	1994-05-26
K935067	Aquaplast	Anholt Technologies Inc.	IYE	Class II	1994-05-26
K934928	Insite Filter & Tubing Set	Andronic Devices, Ltd.	HIF	Class II	1994-05-26
K934926	Insite Model 20 & Model 15 Insufflators	Andronic Devices, Ltd.	HIF	Class II	1994-05-26
K934686	Molybdenum/rhodium Filters	Continental X-Ray Corp.	IZO	Class I	1994-05-26
K933767	Forceps, Biopsy Gynecological Instru/biopsy	Mahe-Medizintechnik	HFB	Class I	1994-05-26
K932035	Non-Linting Delivery Blanket	Amsco Sterile Recoveries, Inc.	KNC	Class II	1994-05-26
K931816	Vesta-Syde(r) Interim Instr Decontamination System	Calgon Vestal Div.	LRJ	Class I	1994-05-26
K931342	Lph	Calgon Vestal Div.	LRJ	Class I	1994-05-26
K922931	Thermapost Endodontic Root Canal Post	Tulsa Dental Products LLC	ELR	Class I	1994-05-26
K913515	Total Containment Device	Denco	KPF	Class II	1994-05-26
K942202	Suction and Irrigation Tubes	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-05-25
K942201	Laparoscopy Dilation System	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-05-25
K940106	Keratoplasty Suturing Lens	Visionary Technologies of Miami, Inc.	HPX	Unclassified	1994-05-25
K934670	Dg 3P System	Medelec, Ltd.	GWQ	Class II	1994-05-25
K934419	Ureteral Catheter and Accessories	Urological Associates of Central Jersey P.A.	EYK	Class I	1994-05-25
K930918	Hydrot	Sanker Intl., Inc.	ILO	Class II	1994-05-25
K926595	Owens Biopsy Forceps	Owens Industries, Inc.	HFB	Class I	1994-05-25
K922276	Therac 25	Theratronics, Inc.	IYE	Class II	1994-05-25
K942215	Conmed Electrosurgical Grounding Pads	Conmedcorp	GEI	Class II	1994-05-24
K942016	Trach Tie, Ventilator Tubing Holder	Garrett Medical Products	CBH	Class I	1994-05-24
K941952	Surgitek Infuser	Surgitek	FAD	Class II	1994-05-24
K941895	Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating	Scimed Life Systems, Inc.	DQX	Class II	1994-05-24
K941660	Gm Opti*cam Camera with Fiber Optic Light	Gm Engineering, Inc.	KYH	Class II	1994-05-24
K941497	Solarcare Alanine Aminotransferase Micro-Plate Assay	Solarcare, Inc.	CKA	Class I	1994-05-24
K940986	Flutter(r)	Varioraw SA	BYI	Class II	1994-05-24
K940795	Swan-Ganz Cc0/svo2 Thermodilution Catheter	Baxter Edwards	DYG	Class II	1994-05-24
K940651	Sarns Ultrasonic Air Sensor	3M Health Care, Sarns	KRL	Class II	1994-05-24
K934664	Hydragown	Mallinckrodt Group, Inc.	FYA	Class II	1994-05-24
K930955	Cervex-Brush	Rovers B.V.	HHT	Class II	1994-05-24
K942194	Quantum Bi-Polar Electrosurgical Cable	Quantum Instruments Corp.	GEI	Class II	1994-05-23
K941909	Mega Beam Lateral Fire	Hogan & Hartson	GEX	Class II	1994-05-23
K941908	Quantum Mono-Polar Electrosurgical Cable	Quantum Instruments Corp.	GEI	Class II	1994-05-23
K941848	Interacoustics. Hearing Aid Analyzer	Precision Acoustics Ind., Inc.	ETW	Class II	1994-05-23
K941819	Liquid Oxygen Storage Subsystem	Hogan & Hartson	BYJ	Class II	1994-05-23
K941665	Sharps Disposal Container/phlebotomy	Bemis Mfg. Co.	MMK	Class II	1994-05-23
K941664	Sharp Disposal Containers Wall Safe	Bemis Mfg. Co.	MMK	Class II	1994-05-23
K941545	Advantage Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1994-05-23
K941542	Orion Central Line Dressing Change Tray	Regulatory & Marketing Services, Inc.	FRG	Class II	1994-05-23
K941392	Jet Unit (Cj Handpiece)	Dentsply Intl.	ELC	Class II	1994-05-23
K940810	Ciba Corning Acs:180 Auto Chemilumin Syst, Modif	Ciba Corning Diagnostics Corp.	JJE	Class I	1994-05-23
K940707	3M Surgical Mask with Face Sheild	3M Company	FXX	Class II	1994-05-23