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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1795 of 3531

510(k) clearances, page 1795 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982394	Prime & Bond Nt Dual Cure Universal Dental Adhesive System	Dentsply Intl.	KLE	Class II	1998-09-21
K982152	Quick Screen Barbiturate Screening Test Models 9020 and 9021, Quick Screen Pro Multi Drug Screening Test Modl 9152	Phamatech Inc.	DIS	Class II	1998-09-21
K981682	Upro	Abbott Medical	JGQ	Class II	1998-09-21
K981163	Diamedix Is-Cmv Igg Test System	Diamedix Corp.	LFZ	Class II	1998-09-21
K982846	Mtek-1400	Magna Advanced Technologies, Inc.	CCK	Class II	1998-09-18
K982496	Quadrature Lower Extremity Coil, Model # 473Si-42D	Medical Advances, Inc.	MOS	Class II	1998-09-18
K982294	Xomed Silicone Pre-Form Blocks	Xomed, Inc.	KHJ	Class II	1998-09-18
K982215	Manual Resuscitator with Ace	Medical Marketing Concepts	BTM	Class II	1998-09-18
K982182	Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral Adapt0	Radi Medical Systems AB	DXC	Class II	1998-09-18
K982176	Kirwan Surgical Products, Inc. Model 28 1500 Electrosurgery Generator	Kirwan Surgical Products, LLC	GEI	Class II	1998-09-18
K981297	Immulite Om-Ma, Models Lkopz, Lkop1, Lkop5	Siemens Healthcare Diagnostics Inc.	LTK	Class II	1998-09-18
K980816	Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges	Fci Ophthalmics, Inc.	HQX	Class II	1998-09-18
K983003	1 Mass Transit Infusion Catheter, 1 Various	Cordis Neurovascular, Inc.	KRA	Class II	1998-09-17
K982405	Mtek-1000	Magna Advanced Technologies, Inc.	DQA	Class II	1998-09-17
K982179	Trumist Air Entrained Disposable Nebulizer	Trudell Medical	CAF	Class II	1998-09-17
K982171	Hamamatsu Pet Scanner, Model Shr-22000	Hamamatsu Photonics K.K.	KPS	Class II	1998-09-17
K982121	Enzymatic Mitochondrial Antibody (M2) Reagent	Trace Scientific, Ltd.	DBM	Class II	1998-09-17
K981726	Percussivetech HF, Model 2001	Vortran Medical Technology 1, Inc	NHJ	Class II	1998-09-17
K973448	Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469	Beckman Instruments, Inc.	LGD	Class II	1998-09-17
K983133	Tbil	Abbott Medical	CIG	Class II	1998-09-16
K982507	Mini Polyurethane Catheter	Med Institute, Inc.	LJT	Class II	1998-09-16
K982187	Fast-Cath Intra-Cardiac Introducer	Daig Corp.	DYB	Class II	1998-09-16
K982105	Oral Potential Meter (Opm)	Pertec of Wisconsin, Inc.	LFC	Class II	1998-09-16
K974399	Bio-Oss Collagen	Geistlich Pharma AG	LYC	Class II	1998-09-16
K973076	Euromedical Haematuria Foley Catheter	Unomedical Sdn Bhd	EZL	Class II	1998-09-16
K982729	Renew	Bisco Inc	EBF	Class II	1998-09-15
K982539	Hdlc Precipitating Reagent	Ac Biochemicals, Inc.	LBS	Class I	1998-09-15
K982480	Perioview Model Dv-1 Fiberscope and Window Sheath.	Dentalview, Inc.	EIA	Class I	1998-09-15
K982343	Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,e82,e88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3	Pharmacia & Upjohn Company LLC	DHB	Class II	1998-09-15
K982318	Spectrum 800 Curing Unit	Dentsply Intl.	EBF	Class II	1998-09-15
K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	JEY	Class II	1998-09-15
K982135	Oscillomate Ems Nibp Monitor Model 9001	Cas Medical Systems, Inc.	DXN	Class II	1998-09-15
K982111	Various Dental Implants	Biotech Medical Instruments Corp.	DZE	Class II	1998-09-15
K981661	Hemaprompt	Aerscher Diagnostics	KHE	Class II	1998-09-15
K981573	Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia Quantitatve	United Biotech	JFH	Class II	1998-09-15
K981563	Biopak Measurement System	Bio-Research Associates, Inc.	KZM	Class II	1998-09-15
K981144	Clean Source I, Model Cs1000	Aquarius Technologies, Inc.	EIA	Class I	1998-09-15
K970700	Fresenius Polysulfone Hemodialyzers, Both Low and High Flux	Fresenius USA, Inc.	MSE	Class II	1998-09-15
K970321	Bio-Oss Anorganic Bovine Bone	Geistlich Pharma AG	LYC	Class II	1998-09-15
K983127	Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels G2 and G3	Medical Analysis Systems, Inc.	DIF	Class I	1998-09-14
K983019	Carbon Dioxide-Sl Assay, Cat # 253-01	Sekisui Diagnostics P.E.I. Inc.	KHS	Class II	1998-09-14
K982884	Disposable Hand Switching Pencil, Rocker Switch Two Piece, Sb 312Rs, Two Disposable Hand Switching Pencil, Rocker Switch	New Deantronics, Ltd.	GEI	Class II	1998-09-14
K982827	Derma K Er:yag/co2 Laser	Esc Medical Systems, Ltd.	GEX	Class II	1998-09-14
K982749	Monopolar Foot Control Pencil, Model # Sb 112-2	New Deantronics Taiwan Ltd.	GEI	Class II	1998-09-14
K982746	Monopolar Suction Coagulator, Model # Sb 110-1	New Deantronics Taiwan Ltd.	GEI	Class II	1998-09-14
K982743	Disposable Hand Switching Pencil, Push Button with and without Holster, Model #'S Sb 313 Pb, Sb 313 Pbh	New Deantronics Taiwan Ltd.	GEI	Class II	1998-09-14
K982742	Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models Sb 313 Rs, Sb 313 Rsh	New Deantronics Taiwan Ltd.	GEI	Class II	1998-09-14
K982629	Dornier Medilas D	Dornier Surgical Products, Inc.	GEX	Class II	1998-09-14
K982602	Retrograde Rod System	Howmedica Corp.	HSB	Class II	1998-09-14
K982601	Osteo Ic Retrograde/antegrade Femoral Nail	Osteonics Corp.	HSB	Class II	1998-09-14