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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2770 of 3530

510(k) clearances, page 2770 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874381	Bte Hearing Aid Oticon Model E39pl	Oticon, Inc.	ESD	Class I	1987-12-23
K874310	Wire Dressing	Slocum and Neal, Inc.	LDF	Class II	1987-12-23
K874241	Opmi Md Surgical Microscope	Carl Zeiss, Inc.	FSO	Class I	1987-12-23
K874220	Ocs 100 (Ocular Comparator System)	Ocular Instruments, Inc.	HJO	Class II	1987-12-23
K874089	Breathe with Eez (Nasal Dilator)	Breathe with Eez Corp.	LWF	Class I	1987-12-23
K874082	Portable Tracheostomy Humidification Unit	800-Air-Wats, Inc.	CAF	Class II	1987-12-23
K874057	Ophthalmic Tip & Blade Scalpels	Myocure, Inc.	HNN	Class I	1987-12-23
K874041	Devilbiss Model 8500D	The Devilbiss Co.	CAF	Class II	1987-12-23
K874025	2Nd Modified Vinylac Press Pack Denture Resin	Astron Dental Corporation	EBI	Class II	1987-12-23
K873942	Guide Wire Bowl	Condor Medical	DQX	Class II	1987-12-23
K873908	H.r.r. Pseudoisochromatic Color Blindness Test Bk.	Richmond Products, Inc.	HIT	Class I	1987-12-23
K874787	Modified Palladium Seed Model 100	Theragenics Corp.	IWI	Class II	1987-12-22
K874705	Easy-Test Amylase (Amyl), Item Number 19019	Em Diagnostic Systems, Inc.	JEJ	Class II	1987-12-22
K874640	Wako(tm) Autokit Lipase	FUJIFILM Healthcare Americas Corporation	CHI	Class I	1987-12-22
K874625	Emit Convenience Pack: Phenobarbital Assay	Syva Co.	DLZ	Class II	1987-12-22
K874472	Inorganic Phosphorus	Catachem, Inc.	CEO	Class I	1987-12-22
K874056	Ophthalmic Disposable Blades	Myocure, Inc.	HNN	Class I	1987-12-22
K873974	Tilson Trach Guard	Beevers Mfg. & Supply, Inc.	BZA	Class I	1987-12-22
K873699	Ecmo-Temp (Tm) Blood Warming Device	Seabrook Medical Systems, Inc.	DWC	Class II	1987-12-22
K873372	Hva & Homovanillic Acid by Hplc Method	Bio-Rad	CDF	Class I	1987-12-22
K872606	Telesonic Body Stimulator	Telesonic, Inc.	IPF	Class II	1987-12-22
K871835	Glucometer Qc Blood Meter, Ames Gluco System Print	Miles Laboratories, Inc.	CGA	Class II	1987-12-22
K854010	Fructosamine Test (Roche)	Roche Diagnostic Systems, Inc.	LCP	Class II	1987-12-22
K874746	Sealflex Mask	Engineered Medical Systems, LLC	BSJ	Class I	1987-12-21
K874559	Babyflex Patient Circuit	Airoflex Medical, Inc.	BZO	Class I	1987-12-21
K874395	Respirgard II Nebulizer System	Marquest Medical Products, Inc.	CAF	Class II	1987-12-21
K874297	Calibration Gas for Carbon Dioxide Monitor	Liquid Air Corp.	BXK	Class I	1987-12-21
K872628	Gonospot* DNA Probe Culture Confirmation Test	Ortho Diagnostic Systems, Inc.	LSL	Class II	1987-12-21
K874848	Lactate Dehydrogenase Ldh-L	Tech-Co, Inc.	CFJ	Class II	1987-12-18
K874847	Magnesium	Tech-Co, Inc.	JGJ	Class I	1987-12-18
K874812	Multichem Chloride Reagent S0933	Simmler Inc	CHJ	Class II	1987-12-18
K874768	Fukuda Denshi Model Fcp-231	Fukuda Denshi USA, Inc.	DSI	Class II	1987-12-18
K874740	Whiteside Ortholoc Calcar Replacement Hip Stem Pro	Dow Corning Wright	JDG	Class II	1987-12-18
K874708	Easy-Test Glucose (Gluc), Item Number 19008	Em Diagnostic Systems, Inc.	LFR	Class II	1987-12-18
K874703	Emit Convenience Pack: Gentamicin Assay	Syva Co.	LCD	Class II	1987-12-18
K874658	Technicon Ra(r) Analyte (Tbg) (30 C and 37 C)	Technicon Instruments Corp.	CEE	Class II	1987-12-18
K874646	Tdxr Delta-9-Cannabinoids	Abbott Medical	LDJ	Class II	1987-12-18
K874622	Fiagen(tm) Htsh Catalogue Number: 101-301	Cyberfluor, Inc.	JLW	Class II	1987-12-18
K874603	Ciba Corning T4 Lipia (Liposome Immunoassay)	Ciba Corning Diagnostics Corp.	KLI	Class II	1987-12-18
K874553	Envisan Paste	Marion Laboratories, Inc.	KOZ	Class I	1987-12-18
K874547	Kirschner Perform Total Knee System Porous Coated	Kirschner Medical Corp.	JWH	Class II	1987-12-18
K874545	Imack-Mb Test Procedure (Modification)	Intl. Immunoassay Laboratories, Inc.	JHY	Class II	1987-12-18
K874470	Mwi 400 Wound Dressing	Med-West, Inc.	NAD	Class I	1987-12-18
K874387	Pci Model Rs100 Telemetry Monitor	Accucore, Inc.	DXH	Class II	1987-12-18
K874339	Takeda Medical Blood Pressure Meter Model Tm-2620	A and D Engineering, Inc.	DSK	Class II	1987-12-18
K874281	Medix Biotech Ige Visual Screening Test Kit	Medix Biotech, Inc.	DHB	Class II	1987-12-18
K874191	Ndna Antibody Test Kit	Lipogen, Inc.	LRM	Class II	1987-12-18
K873771	Heyer-Schulte(r) One Piece Shunt Vent. Cath. Intro	American V. Mueller	GYK	Class I	1987-12-18
K873190	Mec-I-Tron, Model P-1	Meyer Equipment Company, Inc.	GZJ	Class II	1987-12-18
K874879	Auto Suture(r) Surgiport Dispos Surg Trocar/sleeve	United States Surgical, A Division of Tyco Healthc	GDH	Class I	1987-12-17