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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3149 of 3528

510(k) clearances, page 3149 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831040	Lamoreux-Osi Electrogoniometer	Mizuho Orthopedic Systems Inc	KQX	Class I	1983-07-12
K830999	Dap II Biopsy Guide	Rapid Machine & Tool Corp.	HAW	Class II	1983-07-12
K830948	Weber/stiihmer Femoral Head Prosthesis	Allo Pro Corp.	JDI	Class II	1983-07-12
K830790	Personal Amplifier Module	Electone, Inc.	ESD	Class I	1983-07-12
K830702	Nicolet EMG Satellite	Nicolet Biomedical Instruments	IKN	Class II	1983-07-12
K823475	Brooks Sclerotherapy Cuff	Inmed Corp.	KNT	Class II	1983-07-12
K822689	Portable Monitoring & Screening Spirom.	Boehringer Laboratories, LLC	BZK	Class II	1983-07-12
K822633	Microvel Double Velour Supported 100	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1983-07-12
K822411	System 80 Faceplate-in-the-Ear #F1	Western Advanced Technology, Inc.	EIB	Class I	1983-07-12
K831899	Enswell	Dr. Micheal A. Sabia	IME	Class I	1983-07-07
K831889	Surgeon's Choice Crutch Handle	W.K. Wheeler, Inc.	INP	Class I	1983-07-07
K831833	Mx Camera	Uni-Quatro Industries			1983-07-07
K831832	H-O Camera	Uni-Quatro Industries			1983-07-07
K831828	Teflon Femoral Catheter Mwi 100,10 &	Med-West, Inc.	LFK	Class II	1983-07-07
K831801	Hemoclav Venous Catheter	Exo, Inc.	FIQ	Class II	1983-07-07
K831772	Guillotine Blade	Ortho Pared Instruments, Inc.	HTZ	Class I	1983-07-07
K831770	Artificial Kidney Blood Circuit	Eiken Kizai Co., Ltd.	KOC	Class II	1983-07-07
K831754	Ma 610-Impedance Audiometer	Maico Hearing Instruments, Inc.	ETY	Class II	1983-07-07
K831721	Rionet Hearing Aid -And/or Rion	Rion Acoustic Instruments, Inc.	ESD	Class I	1983-07-07
K831720	Argyle Silicone Trachestomy Tube W/low	Sherwood Medical Co.	BTO	Class II	1983-07-07
K831715	Neurotrac	Hdc Corp.	ETN	Class II	1983-07-07
K831714	Micro-Aire Replacement Surg. Saw Blade	Micro-Aire Surgical Instruments, Inc.	GFA	Class I	1983-07-07
K831713	Non Conductive Anesthesia Facemask	Vital Signs, Inc.	BSJ	Class I	1983-07-07
K831712	Surgical Drill Bits	Medical Specialists in Packaging	HTW	Class I	1983-07-07
K831686	Chlamydia Overby Media	Viromed Laboratories, Inc.	KIT	Class I	1983-07-07
K831635	Acu-Punch	Acuderm, Inc.			1983-07-07
K831626	Urea Nitrogen-Bun-Reagents B6370-11A	American Scientific Products	CDQ	Class II	1983-07-07
K831625	Urea Nitrogen-Bun-Reagents B6360-12	American Scientific Products	CDQ	Class II	1983-07-07
K831603	Titan Ge/ieplate	Helena Laboratories, Corp.	JZR	Class I	1983-07-07
K831577	Trachea/cuff Inflator W/pressure #583	Medical Electronics Corp.	BSK	Class II	1983-07-07
K831561	Amylast-D Test	Sclavo, Inc.	JFJ	Class II	1983-07-07
K831511	Tracheostomy Tube	Implant Technology, Inc.	BTO	Class II	1983-07-07
K831455	Leather Valve Cutter	American V. Mueller	DWS	Class I	1983-07-07
K831427	Cyprane Tec 4 Continuous Flow Vapor.	Fraser Harlake, Inc.	CAD	Class II	1983-07-07
K831406	Restrospective ECG Memory Module	Cardiac Evaluation Center, Inc.			1983-07-07
K831336	Salicylate Assay Kit	Quantimetrix Corp.	DKJ	Class II	1983-07-07
K831321	Gum Machine	The Gum Machine Co.	EFS	Class I	1983-07-07
K831263	Electrophoresis Controls-3 in 1	Corning Medical & Scientific	JJY	Class I	1983-07-07
K831145	Alpha-Stim 350	Electromedical Products, Inc.	GZJ	Class II	1983-07-07
K830919	Occult-Alert	Beta Med Pharmaceuticals, Inc.	KHE	Class II	1983-07-07
K830916	Vita/trac 4 Function Vital Sign Monitor	Bib, Inc.	DRT	Class II	1983-07-07
K830915	Omar	Oxford Medilog, Inc.	DSH	Class II	1983-07-07
K830650	Support Products Example Proset Cast	Isopedix Corp.	ITG	Class I	1983-07-07
K830623	Indirect Fluoro-Kit Hsv	Clinical Sciences, Inc.	GQL	Class II	1983-07-07
K831755	Ma600-Impedance Audiometer	Maico Hearing Instruments, Inc.	ETY	Class II	1983-07-06
K831745	Basal Medium Eagle W/earles Salts, &	Sigma Chemical Co.	KIT	Class I	1983-07-06
K831740	Disopyramide N-Desalkyldisopyramide	Utak Laboratories Inc	DIF	Class I	1983-07-06
K831739	Pentobarbital Toxicology Control	Utak Laboratories Inc	LAS	Class I	1983-07-06
K831722	Ac-22 Autoclave Tape	Armak Tape Division	JOJ	Class II	1983-07-06
K831704	Technicon H6000 System Control	Technicon Instruments Corp.	JPK	Class II	1983-07-06