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 2295 of 3531

510(k) clearances, page 2295 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924005	Sanken Mat	Shima American Corp.	FNM	Class II	1993-06-17
K923941	Irrigation Tray W/ Bulb Syringe & Sterile Saline	American Healthcare Corp.	EYN	Class II	1993-06-17
K923940	Irrigation Tray W/ Piston Syringe & Sterile Saline	American Healthcare Corp.	EYN	Class II	1993-06-17
K923939	Irrigation Tray W/ Bulb Syringe & Sterile Water	American Healthcare Corp.	EYN	Class II	1993-06-17
K923938	Irrigation Tray W/ Piston Syringe & Sterile Water	American Healthcare Corp.	EYN	Class II	1993-06-17
K923560	Accu-Drop i.v. Extension Set	Lamtic, Inc.	FPA	Class II	1993-06-17
K923319	Shawnee Product Kit IV	Absentee Shawnee Bandage Group	KGX	Class I	1993-06-17
K923176	Surgical Instrument Kit, Disposable	Ulti-Med Intl., Inc.	KDD	Class I	1993-06-17
K923175	Surgical Instrument Kit, Disposable	Ulti-Med Intl., Inc.	FMC	Class I	1993-06-17
K922398	4 Sure Tm Enema Bag Set	Boston Pacific Medical, Inc.	FCE	Class I	1993-06-17
K922177	Disposable Multi-Puncture Applicator	Allergy Extract Co.	SCL	Class II	1993-06-17
K922051	Kit Pak's Flushing Kit	Kit Pak, Inc.	KOD	Class II	1993-06-17
K912351	Various Sterile Custom Dressing Trays & Kits	Surgipro, Inc.	LYY	Class I	1993-06-17
K932067	Ethanol Controls, Urine, Levels 1,Ii, and III	Sigma Diagnostics, Inc.	DKC	Class I	1993-06-16
K931970	Abbott Imx2 Analyer	Abbott Medical	JJI	Class I	1993-06-16
K931421	Disposable Steerable Angioscope	Endovascular, Inc.	LYK	Class II	1993-06-16
K931061	Radias Tsh Enzyme Immunoassay	Bio-Rad	JLW	Class II	1993-06-16
K930303	Datascope Multinex Id Plus	Datascope Corp.	CBQ	Class II	1993-06-16
K925905	Kit, Surgical Instrument, Disposable	Kay Medical Concepts	KDD	Class I	1993-06-16
K925608	Scimed Encore(tm) Advantage Kit/essentials Kit	Scimed Life Systems, Inc.	MFY	Class II	1993-06-16
K925529	Wander Care	Care Electronics, Inc.	KMI	Class I	1993-06-16
K924343	Wright Pocket Peak Flow Meter	Ferraris Medical, Inc.	BZH	Class II	1993-06-16
K924243	Tracheostomy Care Kit	Transidyne General Corp.	JOH	Class II	1993-06-16
K924193	Tracheostomy Care Set W/ Hydro Perox(ahc-20-54685)	American Healthcare Corp.	BTO	Class II	1993-06-16
K924187	Instant Memory 2000	Telescan Medical Systems	DXH	Class II	1993-06-16
K920043	Aires	Viva-Tek Assoc., Inc.	CBN	Class II	1993-06-16
K932318	Usdt Opiate Assay Column Catalog No. 9000-200	U.S. Drug Testing, Inc.	DJG	Class II	1993-06-15
K931862	Ninhydrin Reagent	Hardy Diagnostics	JTO	Class I	1993-06-15
K931799	Remel Loracarbef 30 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1993-06-15
K931770	Para-Pak Plus	Meridian Diagnostics, Inc.	LIO	Class I	1993-06-15
K931602	Chemstrip Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1993-06-15
K931535	Emit(r) D.a.u. Barbiturate Assay	Syva Co.	DIS	Class II	1993-06-15
K931383	Zinc Pva	Remel Inc	LIO	Class I	1993-06-15
K931374	Affirm Vpiii Microbial Identification Test	Microprobe Corp.	MLA	Class I	1993-06-15
K931373	Analyzer: Stat Profile Plus 10 Analyzer	Nova Biomedical Corporation	JJY	Class I	1993-06-15
K931326	King Diagnostics Ck Reagent	King Diagnostics, Inc.	CGS	Class II	1993-06-15
K931172	Imx(r) Stat Ck-Mb	Abbott Medical	JHY	Class II	1993-06-15
K930008	Coat-a-Count Intact Pth Irma	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1993-06-15
K926475	Access(r) Thyroxine Assay	Bio-Rad Laboratories Inc.	KLI	Class II	1993-06-15
K926236	Beckman Anti-Streptolysin O Kit	Beckman Instruments, Inc.	GTQ	Class I	1993-06-15
K926066	Bion Mumps-G Antibody Test System	Bion Ent., Ltd.	CAR	Class II	1993-06-15
K925883	Osteonics Microstructured Acetabular Components	Osteonics Corp.	JDJ	Class II	1993-06-15
K925303	Pro-Step Pt Hcg	Disease Detection International, Inc.	JHI	Class II	1993-06-15
K925201	Exactech Femoral Stem	Exactech, Inc.	JDI	Class II	1993-06-15
K924416	Boost, Mice, Gamesys.	Penny and Giles Biometrics, Ltd.	KQX	Class I	1993-06-15
K924142	Codman(tm) Titanium Interlaminar Clamp Kit	Cerenovus, Inc.	KWP	Class II	1993-06-15
K922906	Amplicor Chlamydia Trachomatis Test	Roche Molecular Systems Inc	MKZ	Class I	1993-06-15
K922407	Wells Lamont Cut Resistant Surgical Glove Liners	Wells Lamont Corp.	LYU	Class I	1993-06-15
K922207	Tes-Tape	Lilly Research Laboratories	CGA	Class II	1993-06-15
K932189	In-the-Ear Hearing Aid	Lifestyle Hearing, Inc.	ESD	Class I	1993-06-14