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 3105 of 3528

510(k) clearances, page 3105 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833068	Laminaria Japonica Cervical Dilator	Medi-Spec	HDY	Class II	1984-02-04
K833043	Urometer	Browne Medical, Inc.	FFG	Class II	1984-02-04
K832541	Simplex-2	Gentech Australia	GQN	Class II	1984-02-04
K832483	Mattress Cover, Anti-Microbial	American Threshold Industries, Inc.	FMW	Class I	1984-02-04
K832093	Feeding Gastrostomy Tube	Tri-Med, Inc.	KNT	Class II	1984-02-04
K831784	Hemofiltration System	Gambro, Inc.	KDI	Class II	1984-02-04
K840077	Thioglycollate Medium Tube	Otisville Biotech, Inc.	JSG	Class I	1984-02-03
K840075	Trypticase Soy Broth Tube	Otisville Biotech, Inc.	JSG	Class I	1984-02-03
K840073	Esculin Agar Plate	Otisville Biotech, Inc.	JSH	Class I	1984-02-03
K840071	Dnase Agar W/toludine Blue Plate	Otisville Biotech, Inc.	JSH	Class I	1984-02-03
K834464	Tdx Procainamide	Abbott Medical	LAR	Class II	1984-02-03
K834421	Mueller-Hinton Agar Plate	Otisville Biotech, Inc.	JTZ	Class II	1984-02-03
K834406	Emit Qst Phenytoin Assay	Syva Co.	DIP	Class II	1984-02-03
K834398	Liqui-Sera Tdm Calibrators	Biodiagnostic Intl	DKB	Class II	1984-02-03
K834391	Immuno-Ra	Immunostics, Inc.	DHR	Class II	1984-02-03
K834390	Immuno-Crp	Immunostics, Inc.	DCN	Class II	1984-02-03
K834272	Alexolok Bracket	Alexotek Co.	EJF	Class I	1984-02-03
K834111	Antache Anti-Headache Device	Bio Sig Instruments, Inc.	HCC	Class II	1984-02-03
K834099	Blood Glucose Monitor	Healthdyne, Inc.	JJQ	Class I	1984-02-03
K834086	Contact-K Aptt Reagent	Pacific Hemostasis	GGN	Class II	1984-02-03
K834075	Magnesium B Test	FUJIFILM Healthcare Americas Corporation	JGJ	Class I	1984-02-03
K834056	Schein Cotton Rolls, Non-Sterile	Henry Schein, Inc.	EFN	Class I	1984-02-03
K834046	Luxene Vinyl-Ject 3600-80	Howmedica Corp.	EBF	Class II	1984-02-03
K834000	Tandem Visual Hcg Immunoenzymetric	Hybritech, Inc.	JHI	Class II	1984-02-03
K833960	Ventrex Pregnancy Test Kit Enzyme	Vxr, Inc.	JHI	Class II	1984-02-03
K833929	White Blood Cells Human Tand B	Control Diagnostics	LIZ	Class II	1984-02-03
K833757	Visio-Gem	Espe GmbH (US)	EBF	Class II	1984-02-03
K833502	Radovan Subcutaneous Tissue Expander	American Heyer Schulte	LCJ	Unclassified	1984-02-03
K833419	Labeled 125I Anti-Ige	Allergenetics	DGC	Class II	1984-02-03
K832905	Qualitative Enzyme Immunoassay-Detect	Btc Diagnostics, Inc.	LCX	Class II	1984-02-03
K832867	Fertitube Pregnancy Test #1120	Stanbio Laboratory	JHJ	Class II	1984-02-03
K834493	Evertan Suntan Beds	Oregon Beauty Supply	FTC	Class II	1984-02-01
K834492	Salon -Body Tanning Bed	Grantan	FTC	Class II	1984-01-31
K834357	Ana Trans Tube & Swabs Sterile Pack	Anaerobe Systems	JSL	Class I	1984-01-31
K833921	Agc Total Knee Prosthesis	Zimmer GmbH	JWH	Class II	1984-01-31
K833058	Gen. Purpose Instrument Trays &	Inter-Med, Inc.	FSM	Class I	1984-01-31
K840196	Mini-Beep	C.F. Struck Corp.	INI	Class II	1984-01-30
K840159	Gc-Tect	Uti-Tect, Inc.	JTY	Class II	1984-01-30
K840149	Bmr Powerstim	Bio-Medical Research, Ltd.	IPF	Class II	1984-01-30
K840148	Bmr-16 Clinic Muscle Stimulator	Bio-Medical Research, Ltd.	IPF	Class II	1984-01-30
K840147	Bmr-2 Muscle Stimulator	Bio-Medical Research, Ltd.	IPF	Class II	1984-01-30
K840086	Preserv Mf Fixative 15Ml	Preventive Diagnostics Corp.	LIO	Class I	1984-01-30
K840078	Sabouraud Dextrose Agar Tube	Otisville Biotech, Inc.	JSJ	Class I	1984-01-30
K840072	Bordet Gengou Agar Plate	Otisville Biotech, Inc.	JSG	Class I	1984-01-30
K840070	Egg Yolk Agar Plate	Otisville Biotech, Inc.	JSH	Class I	1984-01-30
K840069	Anaerobic Agar Plate	Otisville Biotech, Inc.	JSG	Class I	1984-01-30
K840068	Bile Esculin Agar Plate	Otisville Biotech, Inc.	JSH	Class I	1984-01-30
K840035	Hayday Irrit-Easer Wand	Hayday Irrit-Easer	ISA	Class I	1984-01-30
K840024	Wheelchair Mechanical	Amico Lab, Inc.	IOR	Class I	1984-01-30
K834603	Transferrin, Antigen, Antibody, Control	Technicon Instruments Corp.			1984-01-30