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 3049 of 3529

510(k) clearances, page 3049 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843054	Deka Solution Admin. Set Dk 302-a	Deka Research & Development Corp.	FPA	Class II	1984-09-13
K842607	Infant Apnea Bed Stimulator Aa-010	Alpha Medical Systems			1984-09-13
K842443	Axiom Stable II Triglycerides Test	Axiom, Inc.	CDT	Class I	1984-09-13
K841425	Jinotti Oxygen/suction Catheter	Research Medical, Inc.	BSY	Class I	1984-09-13
K843493	Patient Guided Knee Exerciser	Richards Medical Co., Inc.	BXB	Class I	1984-09-12
K843368	Kapp Spinal Button	Kapp Surgical GmbH	HTN	Class II	1984-09-12
K843237	Stratus Quinidine Fluorometric Enzyme	American Dade	LBZ	Class II	1984-09-12
K843211	Amikacin Analytical Test Pack Aca	E.I. Dupont de Nemours & Co., Inc.	KLQ	Class II	1984-09-12
K843163	Emit 700 Calibrator a	Syva Co.	DKB	Class II	1984-09-12
K843132	Radionics Mini & Standard Shunt Valve	Radionics, Inc.	JXG	Class II	1984-09-12
K843120	Applelisa Chlamydia Trachomatis Anti	Apple Diagnostic Products	LJC	Class I	1984-09-12
K842937	Acetic Acid 2% V/v	E K Ind., Inc.	GGK	Class I	1984-09-12
K842936	Acetic Acid, 3% V/v	E K Ind., Inc.	GGK	Class I	1984-09-12
K842935	Acetic Acid, 5% V/v	E K Ind., Inc.	GGK	Class I	1984-09-12
K842934	Decolorizing Fluic, Acid-Alcohol 3%	E K Ind., Inc.	PPM	Class I	1984-09-12
K842874	Radiometric Blood Culture Vials, Aerobe	American Micro Scan	JTA	Class I	1984-09-12
K842700	Basildon-Gardner Spinal Frame	Downs Surgical, Ltd.	FWZ	Class I	1984-09-12
K842698	British Spinal Fusion Set	Downs Surgical, Ltd.	FZX	Class I	1984-09-12
K842593	Sucrosep Thyroid Stimulating Hormone	Boots-Celltech Diagnostics, Inc.	JLW	Class II	1984-09-12
K842513	Hemoperfusion Procedure W/redy 2000	bioMerieux, Inc.	FKT	Class II	1984-09-12
K842366	Oxalate Urine Controls Normal & Elevat	Sigma Chemical Co.	JJW	Class I	1984-09-12
K842357	Pm 2000 Dental Unit	Planmeca U.S.A. Inc	EIA	Class I	1984-09-12
K842344	Hastings Bipolar Endoprosthesis	Johnson & Johnson Professionals, Inc.	KWY	Class II	1984-09-12
K840937	Capillary Flow Dialyzers	Travenol Laboratories, S.A.	KOC	Class II	1984-09-12
K843316	Indole Spot Test Kit 270-25	Applied Polytechnology, Inc.	JTO	Class I	1984-09-11
K843261	Angiosystems Standard Arteriogram & Card	Angiosystems, Inc.	DRE	Class II	1984-09-11
K843208	Acufex Arthroscope	Acufex Microsurgical, Inc.	HRX	Class II	1984-09-11
K843050	Gram Stain	Reagent Laboratory, Inc.	JTS	Class I	1984-09-11
K842933	Carbol-Fuchsin, Ziehl-Needsen	E K Ind., Inc.	ICL	Class I	1984-09-11
K842930	Gomori's Trichrome Stain	E K Ind., Inc.	LED	Class I	1984-09-11
K842928	Jenner Blood Stain	E K Ind., Inc.	KJX	Class I	1984-09-11
K842927	Light Green Sf 1%	E K Ind., Inc.	HYS	Class I	1984-09-11
K842926	Methylene Blue Stain, Loeffler	E K Ind., Inc.	KFC	Class I	1984-09-11
K842925	Muci-Carmine Stain, Mayer's Formula	E K Ind., Inc.	HZC	Class I	1984-09-11
K842923	Picric Acid 1% W/v	E K Ind., Inc.	LDW	Class I	1984-09-11
K842919	Schiff Reagent Fuchsin-Sulfurous Acid	E K Ind., Inc.	HZT	Class I	1984-09-11
K842918	Scotts Tap Water Substitute	E K Ind., Inc.	JCC	Class I	1984-09-11
K842916	Sudan IV Herxheimer	E K Ind., Inc.	KKK	Class I	1984-09-11
K842858	Fluid Administration Line W/spike 14-923	Norton Performance Plastics Corp.	FPA	Class II	1984-09-11
K842788	Differential Diag. Occlusal Appliance	Brimms, Inc.	JXL	Class II	1984-09-11
K842785	Stain, Methylene Blue-Eosin	Reagent Laboratory, Inc.	KFC	Class I	1984-09-11
K842739	Pap Stain, Ea-36	E K Ind., Inc.	HZJ	Class I	1984-09-11
K842735	Pap Stain Ea-65	E K Ind., Inc.	HZJ	Class I	1984-09-11
K842731	Formalin-Aceto-Alcohol Fixative	E K Ind., Inc.	IGF	Class I	1984-09-11
K842722	Buffered Saline	E K Ind., Inc.	JCE	Class I	1984-09-11
K842462	Holter Screening Monitor Hs-221	Advantage Medical Systems, Inc.	DRT	Class II	1984-09-11
K842343	Saba-Coombs Mini External Fixator	Zimmer GmbH	JEC	Class II	1984-09-11
K842286	Dia T1, T2 & T3	Diatech, Inc.	JPK	Class II	1984-09-11
K842052	Giardia Guard	Gelman Sciences, Inc.	LIB	Class I	1984-09-11
K834539	Axipac II	Teknar, Inc.			1984-09-11