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 2319 of 3531

510(k) clearances, page 2319 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924361	Vacuplus Tubes with Green Stoppers	Starplex Scientific Corp.	JKA	Class II	1993-03-01
K924292	Cerapall 6 -- Modified	Metalor Dental USA Corp.	EJS	Class II	1993-03-01
K925989	Kendall Tru-Close Infection Control Evacuator	Kendall Healthcare Products Co. Div.Of Tyco Health	GCY	Class I	1993-02-26
K925805	Kendall Wound Drainage Systems-Trocars	Kendall Healthcare Products Co. Div.Of Tyco Health	GBX	Class I	1993-02-26
K925793	Teleshare 910	Dejarnette Research Systems	LLZ	Class II	1993-02-26
K925725	Contour Mammography System, Model Number M-Ctr	Bennett X-Ray Corp.	IZH	Class II	1993-02-26
K925721	Kodak Ektascan Cp Primary High Freq. Vid.interface	Eastman Kodak Company	LMA	Class II	1993-02-26
K925150	Modified Articulating Endoscopic Clamp	United States Medical Corp.	GEI	Class II	1993-02-26
K924543	Dsp Screening Audiometer	Micro Audiometrics Corporation	EWO	Class II	1993-02-26
K924228	Omegascope	Omega Universal Technologies, Ltd.	FBN	Class II	1993-02-26
K923800	Pressure Gauge	Innovations for Mechanical Ventilation, Inc.	BSK	Class II	1993-02-26
K923713	Microstar	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-02-26
K923007	At-2	Qualitone	EWO	Class II	1993-02-26
K922958	Kb58-Kf	Jeneric/Pentron, Inc.	EJS	Class II	1993-02-26
K921838	Acucise Ureteral Cutting Catheter	Applied Urology, Inc.	EYB	Class II	1993-02-26
K920871	J-Lloyd Arterial Embolectomy Catheter	J-Lloyd Medical, Inc.	DXE	Class II	1993-02-26
K913581	Wilde Adhesive Bonding System	Wilde-USA, Inc.	KLE	Class II	1993-02-26
K910825	Orion Yag Laser System Ear, Nose, & Throat Applic.	Pfizer Laser Systems	GEX	Class II	1993-02-26
K930269	Cobas-Fp Tdm Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1993-02-25
K926345	Triodothyronine (Tc) Coated Tube Ria	Monobind, Inc.	CDP	Class II	1993-02-25
K926172	Series 1500 Defibrillator, Modification	Marquette Electronics, Inc.	MKJ	Class III	1993-02-25
K925411	Model 2041-Pc/st Cardiac Telemetry Monitor	Accucore, Inc.	DSI	Class II	1993-02-25
K924961	Hmp 4000 Interferential Stimulator	Hmp 4000, Inc.	LIH	Class II	1993-02-25
K924562	Catheter Introducer	Luther Medical Products, Inc.	DYB	Class II	1993-02-25
K924554	Clarus Serirs 2200 Semi-Rigid Endoscope	Clarus Medical Systems, Inc.	LYK	Class II	1993-02-25
K923166	Vidas Toxoplasma Gondii Igm Asssay	Biomerieux Vitek, Inc.	LGD	Class II	1993-02-25
K923054	Witt Biomedical Series II-Ep	Invivo Corporation	MHX	Class II	1993-02-25
K922887	Cryp Check in-Vitro Coagulation Control System	Precision Biologicals, Inc.	GGN	Class II	1993-02-25
K922009	Disposable Surgical Extension Cable Model S-101	Remington Medical	DSA	Class II	1993-02-25
K921052	Fresenius Variable Fill Monitor	Fresenius USA, Inc.	KDJ	Class II	1993-02-25
K913247	Solcotrans Orthopaedic Drainage/reinfusion System	Solco Basle, Inc.	CAC	Class II	1993-02-25
K913177	Solcotrans Orthopaedic Drainage/reinfusion System	Solco Basle, Inc.	CAC	Class II	1993-02-25
K911617	Urotech Catheter	Urotech U.S.A., Inc.	EZL	Class II	1993-02-25
K915779	Affinity Bed Model 3600 Series	Hill-Rom Inc.	KNC	Class II	1993-02-24
K930274	Thyroid Microsomal Antigen Auto-Antibody Enzyme	Joldon Diagnostics	JZO	Class II	1993-02-23
K926007	Accessory to Piston Syringe	Martech Medical Products	FMF	Class II	1993-02-23
K925669	Devmed Lens Wash Sheath	Devmed Corp.	GCJ	Class II	1993-02-23
K925611	Hi Chem Electrolyte Reference Reagent	Hichem Diagnostics	JGS	Class II	1993-02-23
K925565	Magnetic Retriever	Cook Incorporated	GCJ	Class II	1993-02-23
K925545	Skintemp, Modification	Biocore	KGN	Unclassified	1993-02-23
K925416	Symbiosis Bone Marrow Biopsy Needle	Boston Scientific Corporation	GAA	Class I	1993-02-23
K925410	Symbiosis Hemostatic Wand	Boston Scientific Corporation	GCJ	Class II	1993-02-23
K925183	Biosign(tm) Mono-Infect Mono Hetero Antibody Test	Princeton Biomedix	KTN	Class II	1993-02-23
K925101	Systemate Plus Calibrator	Em Diagnostic Systems, Inc.	JIX	Class II	1993-02-23
K924969	Phototherapy Timer	National Biological Corp.	FTC	Class II	1993-02-23
K924769	Immunoglobulins G, a & M and Light Chain Specific	The Binding Site	CFF	Class II	1993-02-23
K924767	Immunoglobulins G, a & M Light Chain Specific	The Binding Site	CFF	Class II	1993-02-23
K924644	Endostats, Microstats, Accustats	Laserscope	GEX	Class II	1993-02-23
K924497	Stat Profile 9 Analyzer	Nova Biomedical Corporation	CHL	Class II	1993-02-23
K924061	Cancer Antigen Control	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	JJY	Class I	1993-02-23