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 2275 of 3531

510(k) clearances, page 2275 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931662	Lead Introducer Set, Various Models and Sizes	Pace Medical	DYB	Class II	1993-08-31
K931449	Msp Ophthalmic (Eye Spud)	Medical Sterile Products, Inc.	HNA	Class I	1993-08-31
K926516	Dantec Magnetic Stimulator Magpro	Dantec Medical, Inc.	GWF	Class II	1993-08-31
K926267	Mobilaire Liquid Oxygen Systems	Invacare GmbH	BYJ	Class II	1993-08-31
K926191	Sigma 7000 and Sigma70002	Sigma	FRN	Class II	1993-08-31
K926097	Cybilnate(r) Umbilical Catheter	Cyex Medical Technologies, Inc.	FOZ	Class II	1993-08-31
K925951	Readar	Alamar Biosciences Laboratory, Inc.	LRG	Class II	1993-08-31
K933304	Anatomic Modular Knee (Amk) Posterior Stabilized	Depuy, Inc.	JWH	Class II	1993-08-30
K933053	Abuscreen Online(r) for Cocaine Metabolite, Modif	Roche Diagnostic Systems, Inc.	DIO	Class II	1993-08-30
K932921	Percutaneous Introducer for Vena Cava Filter Syst	B. Braun Vena-Tech	DTK	Class II	1993-08-30
K932338	Magnetom P8	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-08-30
K931398	Gm Swivel Video (Tm) Irrigator	Gm Engineering, Inc.	KAR	Class I	1993-08-30
K926000	9.5 Fr Sidewinder Dl Intra-Aortic Ballon Catheter	Boston Scientific Corporation	DSP	Class II	1993-08-30
K922208	Fukuda Denshi Model Uf-4500	Fukuda Denshi USA, Inc.	IYO	Class II	1993-08-30
K925362	Sub-Q-Set(r) Subcutaneous Infusion Set	Baxter Healthcare Corporation	FPA	Class II	1993-08-28
K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	BD Becton Dickinson Vacutainer Systems Preanalytic	CAZ	Class II	1993-08-27
K932218	Cardiac Cath or Angiographic Trays	Associated Medical Products Co.	DQO	Class II	1993-08-27
K931932	Dressing Change Tray-Modified	Medsurg Industries, Inc.	MCY	Class II	1993-08-27
K931611	Percutaneous Tracheostomy Tube Kit	Crandall Medical Devices	JOH	Class II	1993-08-27
K930539	Medcomp(r) Continuous Anesthesia Tray	Medical Components, Inc.	BSO	Class II	1993-08-27
K926269	Procedure Kit	General Medical Co.	LRO	Class II	1993-08-27
K925288	Tracheostomy Kit	Ajs Medical Co., Inc.	JOH	Class II	1993-08-27
K925018	IV Prep Kit W/o Dressing (Non-Sterile)	Customed, Inc	LRS	Class II	1993-08-27
K925017	IV Prep Kit (Non-Sterile)	Customed, Inc	LRS	Class II	1993-08-27
K924697	Flexiflo Laparoscopic Gastrostomy Kit	Abbott Medical	KNT	Class II	1993-08-27
K924192	i.v. Start Kit (Ahc-50-54954	American Healthcare Corp.	KGX	Class I	1993-08-27
K924055	N-Pac	National Healthcare Linen Service	FYA	Class II	1993-08-27
K922342	Tri-Tech Inc. Custom Blood Alcohol	Tri-Tech, Inc.	JKA	Class II	1993-08-27
K933426	Stratus(r) Total Thyroxine(t4) Fluor Enzyme Immuno	Baxter Diagnostics, Inc.	CDX	Class II	1993-08-26
K932733	Cordis Catheter Sheath Introducer	Cordis US Corp.	DYB	Class II	1993-08-26
K932549	Abuscreen Online Low-Cutoff Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1993-08-26
K932292	Autotune Device (Atd II) for Picker MRI Systems	Medrad, Inc.	LNH	Class II	1993-08-26
K931896	Pro-Flo System	Lafayette Pharmacal, Inc.	FCE	Class I	1993-08-26
K930856	Psoralite	Daavlin Co.	FTC	Class II	1993-08-26
K926161	Res Q Air System Model Ht-1000	C.F. Electronics, Inc.	BTT	Class II	1993-08-26
K925466	Conduct Aloe Gel, #Up239-8Fl. Oz/#up245 G-1 Gallon	Uni-Patch, Inc.	GYB	Class II	1993-08-26
K924667	Aerosol Charging Adaptor (for Use W/minineb Only)	Vortran Medical Technology 1, Inc	CAF	Class II	1993-08-26
K921683	Pencil Point Spinal Needle	Hart Enterprises, Inc.	BSP	Class II	1993-08-26
K933661	Insufflator Tubing Kit W/filter	Eagle Medical, Inc.	GCJ	Class II	1993-08-25
K933315	Radias B12 Enzyme Immunoassay	Bio-Rad	CDD	Class II	1993-08-25
K932570	Mark I Humidifier	C.F. Electronics, Inc.	BTT	Class II	1993-08-25
K932470	Langgasse 90	Happersberger Otopront GmbH	ETF	Class I	1993-08-25
K932395	Vlc Dr Material	Dentsply Intl.	EBF	Class II	1993-08-25
K931891	Triglycerides	Em Diagnostic Systems, Inc.	CDT	Class I	1993-08-25
K931834	King Sodium/potassium Standard Modified	King Diagnostics, Inc.	JIS	Class II	1993-08-25
K931371	Denrick Speech Aid (Dr-1)	Denrick Corp.	ESE	Class I	1993-08-25
K931346	Ferno-Washington Incubator Transporter,# 29-It	Ferno	FPL	Class II	1993-08-25
K931101	Eclipse 2100(Tm) Model 32, Modification	Cardiogenes	GEX	Class II	1993-08-25
K930903	Probe Personal Preference Non-Ster. Pat. Exam.glov	Glove India Private, Ltd.	LYY	Class I	1993-08-25
K930857	Modissa 90 S.r.l. Spectacle Frames	Modissa 90 SRL	HQZ	Class I	1993-08-25