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 1473 of 3531

510(k) clearances, page 1473 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030853	Steritite Perforated Base Rigid Reusable Sterilization Container System with Scf02-Polypropylene Non-Woven Disposable Fi	Case Medical, Inc.	FRG	Class II	2003-03-21
K030768	Cliniqa Liquid Qc Cardiac Marker Control Levels 1, 2 & 3, Tri-Level	Cliniqa Corporation	JJT	Class I	2003-03-21
K030731	M2376a Devicelink System	Philips North America LLC	MWI	Class II	2003-03-21
K030657	Siemens Infinity Gateway Suite, Model Vf2	Siemens Medical Solutions	MHX	Class II	2003-03-21
K030615	Infinity Explorer	Siemens Medical Solutions USA, Inc.	MSX	Class II	2003-03-21
K030610	Pod Pac-20M	Portable Ophthalmic Devices, Inc.	IYO	Class II	2003-03-21
K030590	Cla Allergen-Specific Ige Assay-Latex Allergen (K82)	Canon Medical Diagnostics USA, Inc.	DHB	Class II	2003-03-21
K030579	Bd Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-03-21
K030575	Modification to Solar 9500 Information Monitor	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-03-21
K030560	Powderfree Latex Examination Gloves with Grape	Pt.Shamrock Manufacturing Corp.	LYY	Class I	2003-03-21
K030397	Autostat II Anti-B-2 Glycoprotein I Iga Elisa	Hycor Biomedical	MSV	Class II	2003-03-21
K030333	Latex Examination Glove,powedered Type II, Low Modulus,with Protein Labling Claim	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	2003-03-21
K030331	On-Line Powder-Free Latex Examination Glove, Type Ii,low Modulus, with Protein Labeling Claim	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	2003-03-21
K030168	Agc Cem	Wieland Dental + Technik GmbH & Co. KG	EMA	Class II	2003-03-21
K030114	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2003-03-21
K030107	100Mm Wallstent Rx Biliary Endoprosthesis, Models M00569800 8Mm, M00569810 10Mm	Boston Scientific Corporation	FGE	Class II	2003-03-21
K030032	Crosseal Application Device	Omrix Biopharmaceuticals, Ltd.	FMI	Class II	2003-03-21
K024329	Ji-Ee Electric Scooter, Elegance Es 3	Ji-Ee Industry Co., Ltd.	INI	Class II	2003-03-21
K024287	Fixobridge 3-Cement	Advanced Healthcare Ltd.	EMA	Class II	2003-03-21
K024282	Acrylic	Inovativ, LLC	EBG	Class II	2003-03-21
K024260	Candela Gentlelase Family of Laser Systems	Candela Corporation	GEX	Class II	2003-03-21
K024132	Chromophare X 65	Berchtold Holding GmbH	FSY	Class II	2003-03-21
K023078	Bptru Vital Signs Monitor, Model Bpm-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor	Vsm Medtech, Ltd.	DXN	Class II	2003-03-21
K022873	Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)	International Biomedical, Ltd.	KGO	Class I	2003-03-21
K022465	Modification to Nasal-Aire	Innomed Technologies	BZD	Class II	2003-03-21
K022212	Portex Percutaneous Dilatational Tracheostomy Kits	Mentor Medical Limited	JOH	Class II	2003-03-21
K022198	Endoscope Set for Magnetic Resonance (Mr), Models 8767.412, 8767.121 & 8767.452	Richard Wolf Medical Instruments Corp.	GWG	Class II	2003-03-21
K021033	Stimuplex-Dig-Rc Nerve Stimulator	B.Braun Medical, Inc.	BXN	Class II	2003-03-21
K020102	Iqteq Spirometer	Iqteq Development	BZG	Class II	2003-03-21
K030814	Invacare Adventure Series Scooters, Models Adventure Sx-3 & Lx-3	Invacare GmbH	INI	Class II	2003-03-20
K030706	Ebi Dynafix Compression Bone Screw	Ebi, LLC	HWC	Class II	2003-03-20
K030698	Aesculap - Miethke Shunt System W/ Nph-Dsv	Aesculap Inc	JXG	Class II	2003-03-20
K030647	Eva Digital Dental X-Ray System	Afp Imaging Corp.	EHD	Class II	2003-03-20
K030597	Synthes 3.5Mm Titanium Lcp Proximal Tibia Plates	Synthes (USA) Products LLC	HRS	Class II	2003-03-20
K030537	Digi-Pro Tens/wl-2203B,2204b,2204b-P1,2204b-P2,2205b	Well-Life Healthcare Limited	GZJ	Class II	2003-03-20
K030501	X-Series Integral Lateralized Hip Components	Zimmer GmbH	LPH	Class II	2003-03-20
K030500	Oria Zenith	Ortho Tec, LLC	KWQ	Class II	2003-03-20
K030411	Proximate Pph Hemorrhoidal Circular Stapler and Accessories, Model Pph03	Ethicon Endo-Surgery Inc	GDW	Class II	2003-03-20
K030378	Stryker Leibinger Cranial Fixation System	Stryker Corp.	GXN	Class II	2003-03-20
K030368	Karl Storz Megafix-T Titanium Interference Screw	Karl Storz Endoscopy-America, Inc.	HWC	Class II	2003-03-20
K030269	Genicon Clip Applier	Genicon, LC	FZP	Class II	2003-03-20
K030200	Powdered Synthetic Vinyl Patient Examination Gloves, White	Kaohsiung Brothers Products Corp.	LYZ	Class I	2003-03-20
K030149	Medtronic Minimed Sof-Site Infusion Set, Models Mmt-359S6, Mmt-359M6, Mmt-359L6, Mmt-359S9, Mmt-359M9, and Mmt-359L9	Avail Medical Products, Inc.	FPA	Class II	2003-03-20
K030117	Enhance Sperm Freeze	Conception Technology, Inc.	MQL	Class II	2003-03-20
K024291	Arthrex Continuous Wave III Arthoscopy Pump, Model Ar-6475	Arthrex GmbH	HRX	Class II	2003-03-20
K024012	Oec 9800 E/cv+ Digital Mobile Imaging System	GE Healthcare	JAA	Class II	2003-03-20
K024009	Cryoprobe	H&o Equipments Inc.	GEH	Class II	2003-03-20
K023692	Global Modular Replacement System Adapter	Howmedica Osteonics Corp	LWJ	Class II	2003-03-20
K023487	Histofreezer Wart Removal System or Other Proprietary Name	OraSure Technologies, Inc.	GEH	Class II	2003-03-20
K023192	Stryker Biozip Suture Anchor	Stryker Corp.	HWC	Class II	2003-03-20