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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3050 of 3529

510(k) clearances, page 3050 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K833594	Fukuda Denshi Fx-302 Auto/three Chan	Brentwood Instruments, Inc.	DRT	Class II	1984-09-11
K842899	Curity Suprapubic Drainage System	The Kendal Co.	LJE	Unclassified	1984-09-10
K842866	Urethral Catheterization Tray	Inmed Corp.	KOD	Class II	1984-09-10
K842313	Elvi 146 Seroscan	Logos Scientific, Inc.	JQT	Class I	1984-09-10
K842228	Aimed Foley Catheter Various Sizes	Tech-Cons Ltd., Intl.	KOD	Class II	1984-09-10
K842131	Formaclear- & Multiple	Rna Medical Corp.	FKQ	Class II	1984-09-10
K842119	Ostomy or Urostomy Abdominal Belt Os	Atlas Surgical Belt Co., Inc.	EXB	Class I	1984-09-10
K841986	Protomed/towic Nasogastric Tube Drainage Bag	Protomed Corp.	KNT	Class II	1984-09-10
K842152	Sickling Hemoglobin Controls, Normal	Isolab, Inc.	GHM	Class II	1984-09-09
K843414	Top Hypodermic Syringe Piston	Top Surgical Manufacturers Co.	FMF	Class II	1984-09-07
K843402	Molinea Underpads	Paul Hartmann AG	KME	Class I	1984-09-07
K843364	Differentiation Disks Bile Esculin	Difco Laboratories, Inc.	JSF	Class I	1984-09-07
K843271	Systemate Ck-Total - 67206	Em Diagnostic Systems, Inc.	CGS	Class II	1984-09-07
K843249	T-Type IV Extension Set	Strato Medical Corp.	FPA	Class II	1984-09-07
K843180	Salicylate Test	Sclavo, Inc.	DKJ	Class II	1984-09-07
K843179	Creatinine Test	Sclavo, Inc.	CGX	Class II	1984-09-07
K843178	Total Bilirubin Test	Sclavo, Inc.	CIG	Class II	1984-09-07
K843172	Augmentin 30 Mcg Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1984-09-07
K843144	K-Bass Lo Frequency Hearing Aid	Etymotic Research, Inc.	ESD	Class I	1984-09-07
K843134	Mobile Operating Table Heidelbergs 1130	Stierlen-Maquet AG	GDC	Class I	1984-09-07
K843121	Guide to the Knee	Dyonics, Inc.	BWN	Class I	1984-09-07
K843115	Sterile Solution Bowl	E.M. Adams Co., Inc.	KDD	Class I	1984-09-07
K843104	Albumin Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CIX	Class II	1984-09-07
K843098	Apco Fissure Sealer & Bonding Agent	Scientific Pharmaceuticals, Inc.	EBC	Class II	1984-09-07
K843072	Ever-Bond V Glass Lonomer Restorative	Kerr Corporation (Danbury)	EBF	Class II	1984-09-07
K843007	Cardi-Ck Eia Test Kit Ck-Mb Isoenzyme	Intl. Immunoassay Laboratories, Inc.	JHS	Class II	1984-09-07
K842929	Hayem Diluting Fluid	E K Ind., Inc.	GIF	Class I	1984-09-07
K842924	Orange G, 1%	E K Ind., Inc.	HZH	Class I	1984-09-07
K842922	Picric Acid Saturated Solution	E K Ind., Inc.	LDW	Class I	1984-09-07
K842921	Rees & Ecker Dilution Fluid	E K Ind., Inc.	GLG	Class I	1984-09-07
K842917	Schiff Reagent, Pas Stain	E K Ind., Inc.	HZT	Class I	1984-09-07
K842914	Wright Stain Buffer	E K Ind., Inc.	JCC	Class I	1984-09-07
K842913	Wright Stain Fixative	E K Ind., Inc.	LDZ	Class I	1984-09-07
K842848	Code-a-Well 350 Microtitration Strips	Plastic Injectors, Inc.	JTC	Class I	1984-09-07
K842783	Aca Barbiturates Screen Analy Test Pack	E.I. Dupont de Nemours & Co., Inc.	DIS	Class II	1984-09-07
K842737	Carnoy's Solution	E K Ind., Inc.	IGM	Class I	1984-09-07
K842694	Terumo Sensibead Eia Thyroid Uptake Kit	Terumo Medical Corp.	KHQ	Class II	1984-09-07
K842684	Diatrol Blood Glucose Test Sys	BD Becton Dickinson Vacutainer Systems Preanalytic	CGA	Class II	1984-09-07
K842629	Home Nutribag Mixing Container 3000Ml	Medical & Pharmaceutical Supplies, Inc.	KPE	Class II	1984-09-07
K842628	Home Nutribag Mixing Container 1000Ml	Medical & Pharmaceutical Supplies, Inc.	KPE	Class II	1984-09-07
K842528	Amizyme-Toxoplasma Gondii Kit	Amico Lab, Inc.	LGD	Class II	1984-09-07
K842127	American Medical Optics Imaging Sys	American Medical Optics	IYO	Class II	1984-09-07
K841934	Radioear M430 Pp	Radioear Corp.	ESD	Class I	1984-09-07
K841520	Cmv Latex Agglutination Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	LJO	Class II	1984-09-07
K843252	African Green Sv 5/Sv 40	Viromed Laboratories, Inc.	KIR	Class I	1984-09-06
K843251	Rd Cells	Viromed Laboratories, Inc.	KIR	Class I	1984-09-06
K843250	Bhk-21	Viromed Laboratories, Inc.	KIR	Class I	1984-09-06
K843173	Cell-Matics Viral Transport Pack	Difco Laboratories, Inc.	JTW	Class I	1984-09-06
K842446	Dilu-Matic 140	Abbott Diagnostics	GKH	Class I	1984-09-06
K842310	Hematology Analyzer	Hml Inc/Biotechnology Transfer	JKL	Class I	1984-09-06