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 1489 of 3531

510(k) clearances, page 1489 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023222	Isocare One Step Sperm Processing Medium Cat# 2207-12	Invitrocare Inc	MQL	Class II	2002-12-26
K022723	Mastel 1 Folder Implantation System	Mastel Precision, Inc.	KYB	Class I	2002-12-26
K024107	Femostop Femoral Compression System	Radi Medical Systems AB	DXC	Class II	2002-12-24
K023962	New Star Lasers, Inc. Dove Nd: Yag Laser System, Model: Ns-160	New Star Lasers, Inc.	GEX	Class II	2002-12-24
K023961	Scout Boss	Burke, Inc.	ITI	Class II	2002-12-24
K023841	Ammonia Assay for the Advia 1650	Bayer Diagnostics Corp.	JIF	Class I	2002-12-24
K023784	Raichem Hdl Cholesterol Using Cantrol Hdl Precipitating Tubes on the Cobas Mira Anaylzer	Hemagen Diagnostics, Inc.	LBR	Class I	2002-12-24
K023731	Quickcheck Liquid Chemistry Control (Assayed and Unassayed), Levels 1, 2, and 3	Consolidated Technology	JJY	Class I	2002-12-24
K023667	Rt-Plus Solution & Rt-Plus Modular Solution Knee	Plus Orthopedics	KRO	Class II	2002-12-24
K023634	Bd Phoenix Automated Microbiology System-Gentamicin Gn (0.25-16Ug/ml)	Becton Dickinson & Co	LON	Class II	2002-12-24
K023370	Cheetah I.v.d.s., Model 2002P	Cheetah Medical, Inc.	DQK	Class II	2002-12-24
K023349	Contaflex Gm3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)	Contamac Ltd.	LPL	Class II	2002-12-24
K023241	Telegraph Humeral Nail	Fournitures Hospitalieres Industrie	HSB	Class II	2002-12-24
K022517	Usi-2000 Ultrasound System with Automated Scanning Accessory	U-Systems, Inc.	IYN	Class II	2002-12-24
K021509	Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089	Hygia Health Services, Inc.	JOW	Class II	2002-12-24
K023964	Rusch Microlaryngeal Tube	Rusch Intl.	BTR	Class II	2002-12-23
K023877	Q Lab Quantification Software with Strain Rate Quantification Plug-in	Philips North America LLC	LLZ	Class II	2002-12-23
K023719	Mp-1 Micro Perimeter	Nidek Technologies SRL	HKI	Class II	2002-12-23
K023527	Bd Phoenix Automated Microbiology System - Norfloxacin - 0.25-16 Ug/ml	Becton Dickinson & Co	LON	Class II	2002-12-23
K023396	Amylase Eps-G7 (Liquid) Reagent Set, (Hitachi Analyzers)	Horiba Instruments Incorporated	CIJ	Class II	2002-12-23
K023341	Cornis 5Mp Medical Flat Panel Display System	Barco N.V.	LLZ	Class II	2002-12-23
K023340	Coronis 1Mp Medical Flat Panel Display System	Barco N.V.	LLZ	Class II	2002-12-23
K023339	Imagetile	Barco N.V.	LLZ	Class II	2002-12-23
K023322	Coronis 2Mp Medical Flat Panel Display System	Barco N.V.	LLZ	Class II	2002-12-23
K023293	Med-Tec Bellyboard, Models Mt-Bba-01 & Mt-Bba-02	Medtec LLC	IYE	Class II	2002-12-23
K023272	Disposable Aspiration Needle Na-200H	Olympus Optical Co., Ltd.	FCG	Class II	2002-12-23
K023269	Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls	Instrumentation Laboratory Co.	DCK	Class II	2002-12-23
K023247	Champion 5000 Peripheral Vascular Coil	GE Healthcare Coils	MOS	Class II	2002-12-23
K023246	Amalga Pacs	Global Care Solutions, S.A.	LLZ	Class II	2002-12-23
K023240	St Aia-Pack Ca 19-9	Tosoh Corp.	NIG	Class II	2002-12-23
K023239	Aia-Pack Ca 19-9	Tosoh Corp.	NIG	Class II	2002-12-23
K022690	Paros Crp	Horiba Ltd.	DCN	Class II	2002-12-23
K022500	Dri-Sate Dry Acid Concentrate for Bicarbonate Dialysate	Rockwell Medical	KPO	Class II	2002-12-23
K022086	Aim-V (R) Medium, Model 087-0112	Invitrogen Corporation	NDS	Class II	2002-12-23
K021775	Ltfs230	Varian Medical Systems, Inc.	LNS	Class II	2002-12-23
K024121	Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E and Protein Claim	Siam Sempermed Corp., Ltd.	LYY	Class I	2002-12-20
K024106	Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Vitamin E and Protein Claim	Siam Sempermed Corp., Ltd.	LYY	Class I	2002-12-20
K024060	Modification to Asnis III Cannulated Screw System	Howmedica Osteonics Corp	HWC	Class II	2002-12-20
K024055	Tilite Evo	TiSport, LLC	IOR	Class I	2002-12-20
K024036	Product Line-Combo Stimulator/sequential Stimulator, Model If-5000	Johari Digital Healthcare, Ltd.	IPF	Class II	2002-12-20
K024033	Xtjf-160Af Duodenovideoscope	Olympus Optical Co., Ltd.	FDT	Class II	2002-12-20
K023975	Voyager Linux	Z-Kat, Inc.	HAW	Class II	2002-12-20
K023936	Modification to Mediprime	Algotec Systems, Ltd.	LLZ	Class II	2002-12-20
K023922	Coapt Systems Endotine Device, Model Cfd-101-00197	Coapt Systems, Inc.	HWC	Class II	2002-12-20
K023883	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, Kvo	Halyard Health	MEB	Class II	2002-12-20
K023870	Flexima Biliary Catheter	Boston Scientific/Medi-Tech	FGE	Class II	2002-12-20
K023858	Bd Phoenix Automated Microbiology System	Becton Dickinson & Co	LON	Class II	2002-12-20
K023567	Stat Profile Phox Plus L Analyzer	Nova Biomedical Corporation	CHL	Class II	2002-12-20
K023554	Dual-Energy Vertebral Assessment View Software	GE Lunar Corp.	KGI	Class II	2002-12-20
K023480	Access Total Bhcg	Siemens Healthcare Diagnostics Inc.	JHI	Class II	2002-12-20