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 3025 of 3529

510(k) clearances, page 3025 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844528	Nutrient Broth	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844527	Selenite Broth	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844526	Thioglycollate W/o Dextrose or Indicator	bioMerieux, Inc.	JSG	Class I	1985-01-07
K844525	Selenite Cystine Broth	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844524	Gn Broth	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844523	Campylobacter Thioglycollate Medium	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844522	Sf Broth	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844521	Sim Medium	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844520	Kliger Iron Agar	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844519	Haemophilus I.d. Quad	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844518	Streptococcus Selective Agar	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844517	Columbia Cna Agar W/5% Sheep Blood	bioMerieux, Inc.	JSJ	Class I	1985-01-07
K844516	Starch Hydrolysis Agar W/indicator	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844515	Violet Red Bile Agar	bioMerieux, Inc.	JSI	Class I	1985-01-07
K844514	Dtm Agar	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844513	V Agar	bioMerieux, Inc.	JSH	Class I	1985-01-07
K844426	Albumin Bcp	Boehringer Mannheim Corp.	CJW	Class II	1985-01-07
K844391	Novacor's R-Test 60 & R-Test 160 ECG Recorders	Ams Medical, Inc.	DXH	Class II	1985-01-07
K844287	Adpifa Test for Antibodies to Toxoplasma Gondii	Apple Diagnostic Products	GLZ	Class II	1985-01-07
K844211	Concise Light Cured White Sealant	3M Company	EBC	Class II	1985-01-07
K844108	Renal Systems Peritoneal Access System	Renal Systems, Inc.	FKX	Class II	1985-01-07
K843963	Dialysate Concentrate for Hemodialysis-Liquid/powd	Renal Systems, Inc.	FKQ	Class II	1985-01-07
K843910	Coulter Mean Platelet Volume Calibrator	Coulter Electronics, Inc.	KRY	Class II	1985-01-07
K842096	Glb Varicella-Zoster Virus Fluorescent	Great Lakes Bioscience	GQX	Class II	1985-01-07
K844535	Yersinia Selective Agar	bioMerieux, Inc.	JSI	Class I	1985-01-05
K844778	Sunglasses	B & M Sporting Goods, Inc.	HQG	Class I	1985-01-04
K844747	Viral Transport Media	Hillcrest Biologicals	JSM	Class I	1985-01-04
K844678	Meloy Lab-Antinuclear Antibody Test-Hep-2 Cell Cul	Meloy Laboratories, Inc.	DHN	Class II	1985-01-04
K844473	Hand-Held Slide Reader	Portable Medical Laboratories, Inc.	LIB	Class I	1985-01-04
K844438	Simpliflos Dental Flosser	Valiant Steel & Equipment, Inc.	JES	Class I	1985-01-04
K844425	Behind the Ear Hearing Aids Bernafon X-13	Bernafon LLC	ESD	Class I	1985-01-04
K844402	Sigma Peroxidase Myeloperoxidase Staining Procedur	Sigma Chemical Co.	GIA	Class I	1985-01-04
K844383	Kanamycin 1000 Mcg Differential Disk	Anaerobe Systems	JTO	Class I	1985-01-04
K844382	Vancomycin 5Mcg Differential Disk	Anaerobe Systems	JTO	Class I	1985-01-04
K844381	Colistin 10 Mcg. Differential Disk	Anaerobe Systems	JTO	Class I	1985-01-04
K844380	Bile Differential Disk	Anaerobe Systems	JTO	Class I	1985-01-04
K844370	Bbl Port-a-Cul 21627 Single Swab Culture Collect	Precision Dynamics Corporation	JSM	Class I	1985-01-04
K844369	Bbl Port-a-Cul 21628 Double Swab Sulture Collectio	Precision Dynamics Corporation	JSM	Class I	1985-01-04
K844234	Active Vertical Corrector Appliance	Active Vertical Correctors, Inc.	ECO	Class I	1985-01-04
K844134	Cleanse N Bond II	Lee Pharmaceuticals	DYH	Class II	1985-01-04
K844133	Cleanse N Bond I	Lee Pharmaceuticals	DYH	Class II	1985-01-04
K843794	Latex-R Rickettsii	Health Research, Inc.	GPP	Class I	1985-01-04
K843727	Leukostix Reagent Strips for Urinalysis	Miles Laboratories, Inc.	LJX	Class I	1985-01-04
K843713	Directigen Group a Strep Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GTZ	Class I	1985-01-04
K843601	Access Hemawipe	MedTech Products, Inc.	KHE	Class II	1985-01-04
K843417	Cordia T-M	Cordis US Corp.	LGD	Class II	1985-01-04
K833246	Tympanostomy Tubes-Various	Abco Dealers, Inc.	ETD	Class II	1985-01-04
K844716	Magnifying Spectacles W/plastic Lenses	Gazelle Corp.	HOI	Class I	1985-01-03
K844668	Model 8000 Nd:yag Laser Sys Treatment of Benign Le	Cooper Lasersonics, Inc.	HQF	Class II	1985-01-03
K844551	Hobbs Medical /Jayco Multiple Biopsy Instrument	Gobbs Medical, Inc.	FCL	Class I	1985-01-03