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 3129 of 3528

510(k) clearances, page 3129 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833108	Biotronik I-Unipolar Pe-60/2-13	Biotronik Sales, Inc.	DTB	Class III	1983-10-19
K833104	Biotronik D2k Unipolar Pe-60/4	Biotronik Sales, Inc.	DTB	Class III	1983-10-19
K833101	Biotronik Dyc, Unipolar Pe-60/4-Dyc	Biotronik Sales, Inc.	DTB	Class III	1983-10-19
K833098	Biotronik Dn Unipolar Pe-60/4-Dn &	Biotronik Sales, Inc.	DTB	Class III	1983-10-19
K833054	Gastric Sump Tubes	Medovations, Inc.	KNT	Class II	1983-10-19
K833008	Percutaneous Nephrostomy Catheter	Medical Engineering Corp.	LJE	Unclassified	1983-10-19
K832980	Vxtra Ocutome Kit	Vxtra Corp.	HQC	Class II	1983-10-19
K832950	Scientronics 10K Eye Magnet	Scientific Manufacturer	HPO	Class II	1983-10-19
K832945	Eagle 2000 Sterilizer Series Gas/aera	Amsco Co.	FLF	Class II	1983-10-19
K832938	Ocutome Paratubing Set	Vxtra Corp.			1983-10-19
K832890	Hemacomp 7 or Hematil 7	Texas Intl. Laboratories, Inc.	GKL	Class II	1983-10-19
K832850	Elecath Pacewedge Dual Press. Bipolar	Electro-Catheter Corp.	LDF	Class II	1983-10-19
K832807	Pediatric Illuminating Ureteral	Van-Tec, Inc.	FCW	Class II	1983-10-19
K832781	Curay-Support, Core Build-Up Material	Scientific Pharmaceuticals, Inc.	EBF	Class II	1983-10-19
K832761	Air Fluid Exchange Pump	Intek Int'L, Inc.	FMF	Class II	1983-10-19
K832673	Satelec Prophy Unit Pu-2000	Spelna, Inc.	EIA	Class I	1983-10-19
K832665	Satelec Suprasson Sp 3055	Spelna, Inc.	ELC	Class II	1983-10-19
K832625	Top Three Way Stopcock	Top Surgical Manufacturers Co.	DTL	Class II	1983-10-19
K832561	Epcor Multielectrode Temp. Pervenous	Cordis US Corp.	LDF	Class II	1983-10-19
K832475	Axiom Perfussion Cannula	Axiom Medical, Inc.	DWF	Class II	1983-10-19
K832446	Catarex Diap. Extracapsular Cataract	Calliope Corp.	HQE	Class II	1983-10-19
K832386	Percluder Dl Occluding Balloon	Datascope Corp.	DQO	Class II	1983-10-19
K832298	Baby Light Dosimeter	Rocky Mountain Medical Corp.	LBI	Class II	1983-10-19
K832287	Nova Balloon Thermodilution Infusion	Nova Medical Specialties	DYG	Class II	1983-10-19
K832273	Surgical Stockings	Wells Johnson Co.	DWL	Class II	1983-10-19
K832068	Cody Sacculotomy Tack	Micromedics, Inc.	ESX	Class II	1983-10-19
K832060	Accu-Sphyg	Olympic Medical Corp.	DXN	Class II	1983-10-19
K831973	Hard Contact Lens Case	Moonbeam International, Inc.	HPX	Unclassified	1983-10-19
K831944	Patient Monitor #78832A	Hewlett-Packard Co.	DRT	Class II	1983-10-19
K831943	Patient Monitor 788 33A	Hewlett-Packard Co.	DRT	Class II	1983-10-19
K831895	Blood Oxygenator 50 70/S	Shiley, Inc.	DTZ	Class II	1983-10-19
K831880	Ionescu-Shiley Low Porosity Aortic Graft	Shiley, Inc.	DSY	Class II	1983-10-19
K831865	Ionescu-Shiley Low Porosity Composite	Shiley, Inc.	DSY	Class II	1983-10-19
K831829	Karickhoff Flying Corpuscle Viewer	Surgidev Corp.	HIX	Class I	1983-10-19
K831587	Temp. Repair Kit-Dual Lumen Catheter	Norton Performance Plastics Corp.	LJS	Class II	1983-10-19
K831245	Taylor Printer/auto Inflat-Sphygmomano	Ritter GmbH	DXN	Class II	1983-10-19
K831057	Video-Dilution Tech. Mark I Instrument	Angio Tec Corp.	DXG	Class II	1983-10-19
K832195	Lung Power	Consolidated Medical Technologies			1983-10-18
K833090	Sensory Roller Massager	Maddak, Inc.	ISA	Class I	1983-10-14
K833084	Masterhinge	Mark One Healthcare Products	LGF	Class I	1983-10-14
K833071	Technicon Paracut	Technicon Instruments Corp.	KEO	Class I	1983-10-14
K833022	Air Uterine Displacer-Aud 120	Scientific Sales Intl., Inc.	CCX	Class I	1983-10-14
K833020	Campylobacter Selective Supple-Butzler	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1983-10-14
K833019	Campylobacter Selective Supple-Blaser	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1983-10-14
K833018	Campylobacter-Selective Supple-Skirrow	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1983-10-14
K833016	Tissue Transport Medium	Northern Scientific, Inc.	KIT	Class I	1983-10-14
K833015	Bioplar Cord -Disposable 30-1538	Cerenovus, Inc.	GEI	Class II	1983-10-14
K833004	Paramax Total Bilirubin Reagent	American Dade	CIG	Class II	1983-10-14
K833002	Paramax Phosphorus Reagent	American Dade	CEO	Class I	1983-10-14
K833001	Paramax & Glutamytransferase Reagent	American Dade	JQB	Class I	1983-10-14