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 2026-11-02, 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 2476 of 3531

510(k) clearances, page 2476 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910133	Chloride Reagent (C1), Catalog No. Dr0011/modified	Olympus Corp.	CHJ	Class II	1991-02-27
K910079	Disposable Introducer Sheath	Applied Vascular Devices, Inc.	KDC	Class I	1991-02-27
K905857	Helena Thromboplastin Reagent, Modification	Helena Laboratories, Corp.	GJS	Class II	1991-02-27
K905620	Modified Site Peristaltic Footswitch	Site Microsurgical Systems, Inc.	EBW	Class I	1991-02-27
K905472	Lap Discs	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1991-02-27
K905370	Exactech Bipolar Hip Prosthesis	Exactech, Inc.	KWY	Class II	1991-02-27
K904364	Varian C-Series Clinacs Clinac 600C,2100c,2500c	Varian Assoc., Inc.	IYE	Class II	1991-02-27
K902434	Dia Healing Cap	Dental Imaging Assoc., Inc.	DZE	Class II	1991-02-27
K901712	Guild Maxox Generator (Maxox)	Guild Assoc., Inc.	CAW	Class II	1991-02-27
K901564	Solusponge - S-99	Sie Medical Supply Co., Inc.	QSY	Unclassified	1991-02-27
K910626	J&b Optical Frames	J & B Optical, Inc.	HQZ	Class I	1991-02-26
K910420	Bioclone's Elegance Hcg Elisa Kit	Bioclone Australia Pty, Ltd.	JHI	Class II	1991-02-26
K910416	Abbott Toxo-M Eia High Positive Control	Abbott Medical	LGD	Class II	1991-02-26
K910340	Laparoscopic Aspiration Probe	Davol, Inc.	HET	Class II	1991-02-26
K910240	Cholestat (Tm) Whole Blood Cholesterol Test	Crystal Diagnostics, Inc.	CHH	Class I	1991-02-26
K910105	Protamine Response Test Catalogue Number Prt 200	Accriva Diagnostics, Inc.	GFT	Class II	1991-02-26
K905820	Aca(r) Lactic Dehydrogenase Isoenzyme 1(Ld1) Veri	E.I. Dupont de Nemours & Co., Inc.	JIS	Class II	1991-02-26
K905799	Hfq Series Controls and Generators	Bennett X-Ray Corp.	IZO	Class I	1991-02-26
K905776	Albumin Reagent Set	Biochemical Trade, Inc.	CJW	Class II	1991-02-26
K905771	Coulter Dart Ast (Got) Reagent	Coulter Electronics, Inc.	CIT	Class II	1991-02-26
K905666	M. Cat. Butyrate Disc	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1991-02-26
K905618	Ggt Reagent	Amresco, Inc.	JPZ	Class I	1991-02-26
K905329	Will-Ceram W	Ivoclar North America, Inc.	EJT	Class II	1991-02-26
K905327	Maxigold	Ivoclar North America, Inc.	EJT	Class II	1991-02-26
K905321	Platinum Foil, Various Sizes	Ivoclar North America, Inc.	EIH	Class II	1991-02-26
K905320	Wlw	Ivoclar North America, Inc.	EJT	Class II	1991-02-26
K905302	Denthesive	Kulzer GmbH	KLE	Class II	1991-02-26
K905254	Thackray Orthogenesis Identifit Femoral Hip Prosth	Depuy, Inc.	LWJ	Class II	1991-02-26
K905145	Eclipse Ica Cholesterol	Biotope, Inc.	CHH	Class I	1991-02-26
K904812	Composite Restorative Material/radiopaque	Alpha-Dent	EBF	Class II	1991-02-26
K904645	Hall Transceervical Safe Access Cannula(tm)	Hall Medical Laboratories	HET	Class II	1991-02-26
K904501	Mycoplasma Pneumoniae Antibody Test System	Medical Diagnostic Technologies, Inc.	LJZ	Class I	1991-02-26
K904074	Vitreoretinal Infusion Cannula	Visitec Co.	HMX	Class I	1991-02-26
K903603	Ultramark 9 Ultrasound System (Um 9)	Advanced Technology Laboratories, Inc.	IYO	Class II	1991-02-26
K903468	Dade Protein C Clotting Assay	Baxter Healthcare Corporation	GGP	Class II	1991-02-26
K903026	Es-1000Sp II Smart Dop	Koven and Assoc., Inc.	DPW	Class II	1991-02-26
K902343	Sunglasses	Jasco Products Co., Inc.	HQY	Class I	1991-02-26
K895805	Slidex Rota-Kit 2	Vitek Systems, Inc.	LIQ	Class I	1991-02-26
K910439	Foxell Plus Multiple (Personal Touch Tm)	Lowenkamp Intl., Inc.	LYY	Class I	1991-02-25
K910346	Antimicrobial Ceftriaxone	Alamar	JWY	Class II	1991-02-25
K910345	Antimicrobial Cefoperazone	Alamar	JWY	Class II	1991-02-25
K910237	Modified Model 5330 Av Demand Pulse Generator	Medtronic, Inc.	DTE	Class II	1991-02-25
K910205	Lp-60 Low Pressure Inflation Device	Devices for Vascular Intervention, Inc.	MAV	Class II	1991-02-25
K910112	Bifurcated Vs-1 to Vs-1 Lead Adaptor	Telectronics Pacing Systems, Inc.	DTD	Class II	1991-02-25
K905833	Mrp-5000(1): 2-D Inflow Mr Angiography	Summit World Trade Corp.	LNH	Class II	1991-02-25
K905832	Mrp -5000(1): Version 2.0 Software	Summit World Trade Corp.	LNH	Class II	1991-02-25
K905765	Pilgrim Nitrile Latex Gloves (Various Types)	Tillotson Rubber Co., Inc.	LYY	Class I	1991-02-25
K905686	Sarns Temperature Probe and Connector	3M Health Care, Sarns	DWE	Class II	1991-02-25
K905548	Percutaneous Transluminal Angioplasty Guidewire	Mallinckrodt Medical	DQX	Class II	1991-02-25
K905294	Eub-315	Hitachi Medical Corp. of America	IYO	Class II	1991-02-25