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 2068 of 3531

510(k) clearances, page 2068 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K952133	Sas Salmonella O Poly Positive Antiserum	SA Scientific, Ltd	GRM	Class II	1995-07-21
K952132	Sas Brucella Ams Antiserum	SA Scientific, Ltd	GSM	Class II	1995-07-21
K952049	Tru-Pulse Pulsed CO2 Surgical Laser System	Tissue Technologies, Inc.	GEX	Class II	1995-07-21
K951972	Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths	Cabot Medical Corp.	FBO	Class II	1995-07-21
K951802	Scimed Encore Advantage Kit and the Essentials Kit	Scimed Life Systems, Inc.	DXT	Class II	1995-07-21
K951562	Omnipulse-Max Holmium Laser	Trimedyne, Inc.	GEX	Class II	1995-07-21
K951431	Aquagel Lubricating Jelly	Depuy Healthcare	KMJ	Class I	1995-07-21
K950695	Depuy Motech Moss Spinal System - Pedicle Fixation	Depuy Motech	MNH	Class II	1995-07-21
K950417	Epx-310 Video Processor (Endoscopy)	Marks & Murase	FET	Class II	1995-07-21
K946353	Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay	Mrl Diagnostics	LLM	Class I	1995-07-21
K944040	Planet Thermoplastic Immobilization System	S & S X-Ray Products, Inc.	IYE	Class II	1995-07-21
K942910	Deepvison	Automated Medical Products Corp.	GCJ	Class II	1995-07-21
K953208	Medical Mixture-Clinical Blood Gas Mixtures	Standard Welders Supply Co.	BXK	Class I	1995-07-20
K953037	Custom Canal & Full Concha Instr (Class D Cir Opt)	Midwest City Hearing Aid Center	ESD	Class I	1995-07-20
K952871	Ridges Plus	Octostop, Inc.	KPR	Class II	1995-07-20
K952844	Humid-Vent 2	Gibeck, Inc.	BYD	Class I	1995-07-20
K952824	Neo-Link, Disposable Neonatal Air Way Connector	Intertex Medical	BZA	Class I	1995-07-20
K952816	Lipase Flex Reagent Cartridge	Dupont Medical Products	CHI	Class I	1995-07-20
K952813	Slt Multidimensional Contact Laser System	Surgical Laser Technologies, Inc.	GEX	Class II	1995-07-20
K952786	Triflex Sterile Synthetic Examination Gloves	Baxter Healthcare Corporation	LYZ	Class I	1995-07-20
K952750	Humid-Vent 1	Gibeck, Inc.	BYD	Class I	1995-07-20
K952681	Stryker Hummer II Microdebrider System	Stryker Corp.	ERL	Class II	1995-07-20
K952647	Il Test Lipase	Instrumentation Laboratory Co.	CHI	Class I	1995-07-20
K952574	Karl Storz Insulated Grooved, Skiked, Ablator, Fixed Barrel with Grooves, Coagulating Loop, Depth-Limiting Loop Electros	Karl Storz Endoscopy-America, Inc.	FJL	Class II	1995-07-20
K952404	Safetex Super Hyperallergenic Powderfree Latex Medical Glove	Aladan Corp.	LYY	Class I	1995-07-20
K952127	Boehringer Mannheim Cholesterol Assay	Boehringer Mannheim Corp.	CHH	Class I	1995-07-20
K952067	Cordis Steerable Guidewire	Cordis US Corp.	DQX	Class II	1995-07-20
K951918	Surgical Technologies, Inc. Syringe	Surgical Technologies, Inc.	FMF	Class II	1995-07-20
K951734	Lumix 70B	Emix U.S.A., Inc.	EAP	Class II	1995-07-20
K951394	Karl Storz Pediatric Vancaillie, Manhes Take-Apart Bipolar Forceps, Bipolar Coagulation Electrode	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-07-20
K950949	Coulter Mh025a	Coulter Corp.	GKZ	Class II	1995-07-20
K946056	Absogel Non-Sterile Examination Gloves (Powder-Free)	Ampri Rubberware Industries Sdn Bhd	LYY	Class I	1995-07-20
K945700	Synthes (USA) Anterior Cervical Vertebrae Plate System	Synthes (USA) Products LLC	KWQ	Class II	1995-07-20
K944259	Femostop II	Radi Medical Systems AB	DXC	Class II	1995-07-20
K944232	Autoflo Intra-Op Shed Blood Autortransfustion Sys	Haemonetics Corporation	CAC	Class II	1995-07-20
K944228	Health Images, Inc. Hi-Standard	Health Images, Inc.	LNH	Class II	1995-07-20
K941809	Vinyl Patient Examination Gloves	Cheer & Merit Co., Ltd.	LYZ	Class I	1995-07-20
K923488	Gastranimal Percutaneous Replacement Gastroomy	Applied Medical Technologies	KNT	Class II	1995-07-20
K953260	Sunglasses	Eye Deals	HQY	Class I	1995-07-19
K953245	Nyx Golf Vision System	Nyx Golf, Inc.	HQY	Class I	1995-07-19
K953092	Foster Grant Non Prescription Sunglasses	Foster Grant Group	HQY	Class I	1995-07-19
K953027	Permadyne Penta (High & Low Viscosity)	Espe GmbH & Co. KG.	ELW	Class II	1995-07-19
K952960	Pulpdent Post Cement	Pulpdent Corporation	EMA	Class II	1995-07-19
K952868	Dentaurum Jacket Crown & Root Posts	Dentauraum, Inc.	EBL	Class I	1995-07-19
K952863	Forceps, Biopsy, Non-Electric	Annex Medical, Inc.	FCL	Class I	1995-07-19
K952840	Kenlor Liquid Total Urine Control	Kenlor Industries, Inc.	JJW	Class I	1995-07-19
K952656	Xxl Balloon Dilatation Catheter	Boston Scientific Corporation	KNQ	Class II	1995-07-19
K952434	Endopore Dental Implant Abutments	Innova Corp.	DZE	Class II	1995-07-19
K952079	Imx Digoxin	Abbott Medical	KXT	Class II	1995-07-19
K951922	Administration Sets with Ball Float	Imed Corp.	FPA	Class II	1995-07-19