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 3205 of 3528

510(k) clearances, page 3205 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822468	Psi Total Protein Reagent	Horiba Instruments Incorporated	CEK	Class II	1982-09-14
K822466	Thrombin Time Test	American Dade	GJA	Class II	1982-09-14
K822465	Enzymune System I	Icl Scientific	JJE	Class I	1982-09-14
K822462	G-N Anaerobe Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1982-09-14
K822461	N-S Anaerobe Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1982-09-14
K822460	Lcat Antibiotic Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1982-09-14
K822459	Vcat Antibiotic Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1982-09-14
K822458	Yeast Autolyxate Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1982-09-14
K822453	Visio-Opaquer	Espe GmbH (US)	EBF	Class II	1982-09-14
K822450	Aurafill* Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1982-09-14
K822448	Scissors, Various	J. Sklar Mfg. Co., Inc.	FZT	Class I	1982-09-14
K822445	Hct Centrifuge	Boehringer Mannheim Corp.	GKG	Class II	1982-09-14
K822427	Self-Contained Mobile Ophthal. Oper. .	Surgi-Quip Inc.U	FSE	Class I	1982-09-14
K822418	Ultrachem Enzymatic Chol. Oxidase	EMD Millipore Corporation	CHH	Class I	1982-09-14
K822351	Powder Blowers	Kelleher Corp.	KMA	Class I	1982-09-14
K822319	Re1000 Heart Rate Monitor	Electronic Monitors, Inc.	DRT	Class II	1982-09-14
K822142	Diaglaze	Antraco, Inc.	EJR	Class I	1982-09-14
K822016	Nagashima Sn-Sp Unit and Chair	Kelleher Corp.	ETF	Class I	1982-09-14
K821893	Zimmer Metal Backed Acetabular Cup	Zimmer GmbH	JDI	Class II	1982-09-14
K821866	Oxy-Pmma	Petrarch Systems & Professional Pharm	HPX	Unclassified	1982-09-14
K821804	Rubella Rq Bio-Enzabead Kit	Litton Bionetics	LFX	Class II	1982-09-14
K821803	Qbc Centrifugal Hematology System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKG	Class II	1982-09-14
K821797	Actisorb* Activated Charcoal Cloth Drsg.	Johnson & Johnson Professionals, Inc.			1982-09-14
K821769	Microknife	Biological & Environmental Control Laboratories	EMF	Class I	1982-09-14
K821185	New Support Sys. for Bedridden Patients	Dase Co.	FNL	Class II	1982-09-14
K827993	Mth C/a Mobile C Arm	General Medical Merate S.p.A.			1982-09-13
K827963	Model Ml-850	Merrimack Laboratories			1982-09-13
K827929	Mobilett, Mobile X-Ray Unit	Siemens Medical Solutions USA, Inc.			1982-09-13
K827914	Niic CO2 Laser System Model 3Oz.	Cooper Lasersonics, Inc.			1982-09-13
K827913	Niic CO2 Laser System Model 6Oz.	Cooper Lasersonics, Inc.			1982-09-13
K827861	Introspec a-10	Bioresources Corp.			1982-09-13
K822399	Leeco T4 Quant Diagnostics Test Kit	Leeco Diagnostics, Inc.	CDX	Class II	1982-09-13
K822349	Armstrong V Tube Suction Inserter	Treace Medical, Inc.	JYM	Class I	1982-09-13
K822288	Lh (125I) Radioimmunoassay	Corning Medical & Scientific	CEP	Class I	1982-09-13
K822139	Stimpen	Neuro Technology	BXN	Class II	1982-09-13
K822631	Argyle Duo-Tube	Sherwood Medical Co.	KNT	Class II	1982-09-09
K822547	Capd Belt	American Medical Products LLC	FKX	Class II	1982-09-09
K822525	Laryngoscopes Rigid	Kelleher Corp.	EQN	Class II	1982-09-09
K822524	Ear Spoon	Kelleher Corp.	KBD	Class I	1982-09-09
K822523	Laryngostroboscope	Kelleher Corp.	EQL	Class I	1982-09-09
K822376	Tytan Reuter Bobbin Vent Tube	Treace Medical, Inc.	ETD	Class II	1982-09-09
K822375	Armstrong V Vent Tube	Treace Medical, Inc.	ETD	Class II	1982-09-09
K822374	Buckingham Attic & Antrum Mirror	Treace Medical, Inc.	KAI	Class I	1982-09-09
K822373	Ear Surgery Speculum	Treace Medical, Inc.	EPY	Class I	1982-09-09
K822372	Office Econo-Forceps	Treace Medical, Inc.	KAE	Class I	1982-09-09
K822371	Micro Worktable	Treace Medical, Inc.	JXS	Class I	1982-09-09
K822370	Universal Speculum Holder	Treace Medical, Inc.	EPY	Class I	1982-09-09
K822369	Micro & Mini-Micro Alligator Forceps	Treace Medical, Inc.	KAE	Class I	1982-09-09
K822368	Calibrated Tissue Graft Press	Treace Medical, Inc.	JYW	Class I	1982-09-09
K822269	Nagashima Sn Sound-Proof Chamber-Hearing	Kelleher Corp.	EWC	Class I	1982-09-09