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 2427 of 3531

510(k) clearances, page 2427 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913142	Boden Wheelchair Drainage System	Mno Medical Products	KNX	Class II	1991-09-23
K913128	Hematastat C-70B	Separation Technology, Inc.	GKG	Class II	1991-09-23
K913012	Digital Fluoro Store(dfs) W/numerical Suffixes	Eigen	JAA	Class II	1991-09-23
K913008	Bactidrop(tm) Oxidase	Remel Inc	JTO	Class I	1991-09-23
K913007	Bactidrop(tm) Voges-Proskauer B	Remel Inc	JTO	Class I	1991-09-23
K913006	Bactidrop(tm) Dobell & O'connor Iodine	Remel Inc	JTO	Class I	1991-09-23
K913003	Bactidrop(tm) Voges-Proskauer a	Remel Inc	JTO	Class I	1991-09-23
K913002	Bactidrop(tm) Ferric Chloride (10%)	Remel Inc	JTO	Class I	1991-09-23
K912972	Flexiflo Over the Guidewire Jejunal Feeding Tube	Abbott Medical	FPD	Class II	1991-09-23
K912947	Starpac o.r. Towel	Multi M Intl., Inc.	KKX	Class II	1991-09-23
K912911	Low Porosity (Lp) Vascular Prosthesis	Intervascular, Inc.	DSY	Class II	1991-09-23
K912877	Profuse Infusion System	Lake Region Mfg., Inc.	DQY	Class II	1991-09-23
K912833	Camino Model M420: Monit Inter W/mean Pres Display	Camino Laboratories, Inc.	DSK	Class II	1991-09-23
K912798	Amplantz and Bentson Guidewires	Meadox Medicals, Div. Boston Scientific Corp.	DQX	Class II	1991-09-23
K912753	Xomed-Treace Positrol Footpedal Suction Control	Xomed-Treace, Inc.	GCX	Class II	1991-09-23
K912749	Reflab(tm) Br Syst Pack Liq Reag, Apolipoprotein B	Medical Analysis Systems, Inc.	MSJ	Class I	1991-09-23
K912478	Sevacare Sterile Surgeon's Gloves	Sevaids Industries	KGO	Class I	1991-09-23
K912420	Orthofix Unreamed Tibial Nail System	Scientific Research	HSB	Class II	1991-09-23
K912392	Probe Latex Examination Gloves - Sterile	Glovetex Industries	LYY	Class I	1991-09-23
K912371	Biomerieux Rsv Direct If Kit	Vitek Systems, Inc.	LKT	Class I	1991-09-23
K912347	Bipure 1000	Laser Engineering, Inc.	FYD	Class II	1991-09-23
K912288	Wiltek Standard Cholangiography Catheter	Wiltek Medical, Inc.	FGE	Class II	1991-09-23
K912224	Lifecare CPAP-100	Lifecare Services, Inc.	BZD	Class II	1991-09-23
K912122	Cholangiography Catheter	Wiltek Medical, Inc.	FGE	Class II	1991-09-23
K912020	Anti-DNA Microassay	Diamedix Corp.	LRM	Class II	1991-09-23
K911784	Nortec Robertazzi Nasopharyngeal Airway	North American Sterilization & Packaging Co.	BTQ	Class I	1991-09-23
K911764	Imac2000	Medical Imaging Technologies, Inc.	JAK	Class II	1991-09-23
K911679	Anti-Jo-1 Microassay	Diamedix Corp.	LLL	Class II	1991-09-23
K911604	Mdphone Cellular + Rescue (Defib System)	Medphone Corp.	LDD	Class II	1991-09-23
K911375	G-Pin	Dr.M.A.Galluzzo	HTY	Class II	1991-09-23
K911333	Right Atrial Catheters	Akcess Medical Products, Inc.	DQY	Class II	1991-09-23
K910594	Trac-Wright System, Model Tw2	Dow Corning Wright	DXT	Class II	1991-09-23
K910111	Various Models of Daylight Cassette Holders	Instrumentarium Imaging, Inc.	IZH	Class II	1991-09-23
K910109	Cardioswiss Cm-8	Care Systems, Inc.	DSI	Class II	1991-09-23
K905709	Beckman Diatrac Hemoglobin a Electrophoresis Kit	Beckman Instruments, Inc.	LCP	Class II	1991-09-23
K912789	Lm-100/200Low Flow Insufflator	Leisegang Medical, Inc.	HIG	Class II	1991-09-20
K912777	Cordis 7 French 0.072 I.d. Ptca Guiding Catheter	Cordis US Corp.	DQY	Class II	1991-09-20
K904177	Galix Ma-6C Holter Cassette Recorder	Galix Instrumentacion Biomedica	DSH	Class II	1991-09-20
K904176	Galix Model Ma-6R Holter Reel-to-Reel Recorder	Galix Instrumentacion Biomedica	DSH	Class II	1991-09-20
K913922	Abbott Quickstart Tibc Pretreatment Kit, 5A29-01	Em Diagnostic Systems, Inc.	JMO	Class I	1991-09-19
K913867	Urine Cocaine Metabolite Direct Ria Kit (I-125)	Immunalysis Corporation	KLN	Class II	1991-09-19
K913863	Urine Heroin/morphine Direct Ria Kit (I-125)	Immunalysis Corporation	DJG	Class II	1991-09-19
K913846	Abbott Quickstart Alanine Aminotransfer	Em Diagnostic Systems, Inc.	CKA	Class I	1991-09-19
K913687	Chem-Chex	Streck Laboratories, Inc.	JJY	Class I	1991-09-19
K913534	Vista Hpq System	Philips North America LLC	LNH	Class II	1991-09-19
K913243	Bennett X-Ray Horiz Radio Float/hi-Lo Elev Table	Bennett X-Ray Corp.	IXG	Class I	1991-09-19
K913147	Shimadzu Multi-Directional Diagnostic Table Vs-100	Shimadzu Medical Systems	IXR	Class II	1991-09-19
K913123	Emit(r) 2000 Theophylline Assay/calibrators	Syva Co.	KLS	Class II	1991-09-19
K913048	Sime Trufeel	Sime Health, Ltd.	LYY	Class I	1991-09-19
K913011	Bactidrop(tm) Nitrate a	Remel Inc	JTO	Class I	1991-09-19