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 2111 of 3531

510(k) clearances, page 2111 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945523	Cobas(r)-Fp Reagents for Gentamicin and Cobas(r)-Fp Gentamicin Calibrators	Roche Diagnostic Systems, Inc.	LCQ	Class II	1995-03-09
K945475	Fuji Medical Laser Imager Fl-Im D	FUJIFILM Healthcare Americas Corporation	LMC	Class II	1995-03-09
K945428	Scribe(tm) Diagnostic Imaging Workstation	Multi-Dimensional Imaging, Inc.	LLZ	Class II	1995-03-09
K945280	Dupont Dimension C-Reactive Protein Method	Dupont Medical Products	DCK	Class II	1995-03-09
K945156	Slase 210 Plus Holmium Laser System	New Star Lasers, Inc.	GEX	Class II	1995-03-09
K945061	Noprofile Olbert Catheter System	Meadox Surgimed, Inc.	KOD	Class II	1995-03-09
K944791	Entamoeba Test	Techlab, Inc.	KHW	Class II	1995-03-09
K943292	Candela Sptl Variable Pulse/tunable Pulsed Dye Lasers	Candela Corporation	GEX	Class II	1995-03-09
K943206	Various Tubing	Prn Services, Inc.	FPK	Class II	1995-03-09
K941350	Wilson-Cook Gianturco-Rosch Z-Stent and Introducer	Wilson-Cook Medical Inc.	FGE	Class II	1995-03-09
K936203	Stat Profile Plus 10 Analyzer	Nova Biomedical Corporation	CHL	Class II	1995-03-09
K936066	Stat Profile Plus 9 Analyzer	Nova Biomedical Corporation	KHP	Class I	1995-03-09
K935145	Cyperflo Peripherally Inserted Catheter	Cyex Medical Technologies, Inc.	LJS	Class II	1995-03-09
K950556	Fuji Ortho Lc	GC America Inc.	DYH	Class II	1995-03-08
K950121	France Orthodontie	France Orthodontie	DZB	Class II	1995-03-08
K946043	H5000, H5000l, H5000l Reverse Model H5000c, H5000cg	Rudolf Riester GmbH & Co. KG	ERA	Class I	1995-03-08
K945947	Nellcor Symphony(tm) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony(tm) N-3000 Pulse Oximeter	Nellcor, Inc.	DXN	Class II	1995-03-08
K945597	Altres(r) 170 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-03-08
K945596	Altres(r) 140 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-03-08
K945595	Altrex(r) 200 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-03-08
K945295	Lsvp International Grasping Forceps	Lsvp Intl., Inc.	LQR	Class II	1995-03-08
K945140	Uro-Flo	Mallinckrodt Group, Inc.	LJH	Class II	1995-03-08
K944972	Uro-Gram Cystomrtrogram with Uroflowmetry	Myo/Kinetic Systems, Inc.	EXY	Class II	1995-03-08
K944683	Branemark System 3.3Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1995-03-08
K944234	Tcd or Tcd Neuropathy Star	Jcm Management & Planning Co.	GWI	Class I	1995-03-08
K943942	Trav-Ler Kit	John O. Butler Co.	JEQ	Class I	1995-03-08
K950655	Thermo Massage Unit, Elec. Theraputic Massages	Ultrassage, Inc.	ISA	Class I	1995-03-07
K950514	Tri-Cure Glass Ionomer Orthodontic Band Cement	3M UNITEK Corporation	DYH	Class II	1995-03-07
K950512	American Dental Products (Adp), Fluoride Releasing Glass Ionomer Band Cement	American Dental Products, Inc.	DYH	Class II	1995-03-07
K950195	Karma Wheelchair	Karman Healthcare Inc	IOR	Class I	1995-03-07
K946246	Surgi-Link Bipolar Micro Forceps	Unimed Surgical Products, Inc.	GEI	Class II	1995-03-07
K946032	Fluor Protector	Ivoclar North America, Inc.	LBH	Class II	1995-03-07
K946010	Kao Ying	Kao Ying Industrial Co., Ltd.	LYZ	Class I	1995-03-07
K945964	Kangaroo(r) 524 Enteral Feeding Pump and Administration Sets	Sherwood Medical Co.	LZH	Class II	1995-03-07
K945839	Sas(tm) Qc Antigens for Salmonella Antisera	SA Scientific, Ltd	GRL	Class II	1995-03-07
K945750	Resound(r) Resource(tm)	Resound Corp.	ESD	Class I	1995-03-07
K945670	Kirschner (K-Wire), Steinman Pins	Brasseler USA I, L.P.	JDW	Class II	1995-03-07
K945399	Delta Therm Cold Therapy System	Deltatherm	ILO	Class II	1995-03-07
K945363	Medi Plus Surgeon's Gloves	P.T. Saptindo Surgica	KGO	Class I	1995-03-07
K945294	Dall Miles System Homogeneous Vitallium Cable	Howmedica Corp.	JDQ	Class II	1995-03-07
K945250	Trimport	Gerard Medical Enterprises, Inc.	LJT	Class II	1995-03-07
K945235	Dried Gram-Positive Mic/combo Panels	Baxter Diagnostics, Inc.	LTT	Class II	1995-03-07
K944528	Bblcrystal Anaerobe Id System	Becton Dickinson Microbiology Systems	JSP	Class I	1995-03-07
K943995	Imd Psd 410 Pacemaker Transmitter	Integrated Medical Devices, Inc.	DXH	Class II	1995-03-07
K943893	Percutaneous Grainage Catheter	Menlo Care, Inc.	LJE	Unclassified	1995-03-07
K943563	Comfit Blue Powder Free Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-03-07
K943255	Scipotex Powder Free Surgical Gloves (Unbeaded)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1995-03-07
K943254	Scipotex Powder Free Surgical Gloves (Beaded)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1995-03-07
K940739	Newport Communicat Protocol Interface Adaptor	Newport Medical Instruments, Inc.	MOD	Class II	1995-03-07
K934515	Bias(tm) Fiber Metal Total Hip Stem (Tfb)	Zimmer GmbH	LPH	Class II	1995-03-07