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 2333 of 3531

510(k) clearances, page 2333 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924085	Reconstruction Plate System	Sofamor Danek Mfg., Inc.	HRS	Class II	1992-12-17
K924072	Becton Dickinson Safety-Lok Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1992-12-17
K923990	Fuji Computed Radiography Hi-C652b Dms Crt Image	FUJIFILM Healthcare Americas Corporation	IXK	Class II	1992-12-17
K923812	Centurion Disposable Instruments	Centurion Medical Products, LP	MDM	Class I	1992-12-17
K923786	Polydoros Xs50 and Sx80	Siemens Medical Solutions USA, Inc.	IZO	Class I	1992-12-17
K923446	Sterile Dyna Lok Anterior Plating System	Sofamor Danek Mfg., Inc.	KWQ	Class II	1992-12-17
K923305	Battery Packs	Access / God Loves You	CCK	Class II	1992-12-17
K922564	6 French Catheter	S. and H. Engineering, Inc.	JAQ	Class II	1992-12-17
K922314	Ventilator Interface 9291/4	S & W Medico Teknik	CBK	Class II	1992-12-17
K921699	Es 1500 ECG Demodulator	Epic Systems Corporation	DXH	Class II	1992-12-17
K921429	Solution Administration Set	Sierra Medical Devices	FPA	Class II	1992-12-17
K920802	Alvine Total Ankle	Depuy, Inc.	HSN	Class II	1992-12-17
K920713	Firsttemp Genius	Intelligent Medical Systems	FLL	Class II	1992-12-17
K914821	Crs Radiation Beam Scanner	Consolidated Radiation Services, Inc.	IYI	Class II	1992-12-17
K924898	Quanta Lite(tm) Scl-70 Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-12-15
K924858	Aia-Pack Fer Calibration Verification Test Set	Tosoh Medics, Inc.	DBF	Class II	1992-12-15
K924753	Bioentrics Endolumina Illuminated Bougie	Bioenterics Corp.	HMJ	Class I	1992-12-15
K924684	Microflow	Mountain Medical Equipment, Inc.	CAF	Class II	1992-12-15
K924672	Zymed Telemetry Monitor Model T8010 (Preliminary)	Agilent Technologies, Inc.	DSI	Class II	1992-12-15
K924655	Cox Disposable Endoscope Cleaning Brush(cb-X2)	Cox Medical Ent., Inc.	FEB	Class II	1992-12-15
K924197	Zorba(tm) Igg Removal Reagent	Zeus Scientific LLC	DEW	Class II	1992-12-15
K923967	Patient Exam Gloves (Powder Free)	American Health Products, Inc.	LYY	Class I	1992-12-15
K923872	Bone Marrow Biopsy System	Straumann USA, LLC	GDM	Class I	1992-12-15
K923219	Uresil Specimen Retrieval Bag	Uresil, LLC	GCJ	Class II	1992-12-15
K922807	Fiberlife	Laser Surgical Systems	GEX	Class II	1992-12-15
K922334	Bartels Herpes Simplex Virus 1 Igm Eia	Baxter Diagnostics, Inc.	LGC	Class II	1992-12-15
K922333	Bartels Herpes Simplex Virus 2 Igm Eia	Baxter Diagnostics, Inc.	LGC	Class II	1992-12-15
K921884	Force 2	Medtronic, Inc.	HGI	Class II	1992-12-15
K920737	Lifeshield Vial Adapter	Abbott Medical	FMI	Class II	1992-12-15
K915218	Ultralon Powderfree Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1992-12-15
K911731	Leucoprep(r) Brand Cell Separat Tube W/sodium Citr	BD Becton Dickinson Vacutainer Systems Preanalytic	JCF	Class I	1992-12-15
K925338	Olympus Chloride Reagent	Olympus Corp.	CHJ	Class II	1992-12-11
K924957	Opus(r) Vancomycin	Pb Diagnostic Systems, Inc.	LEH	Class II	1992-12-11
K924751	Solarcare Technologies Corp. Micro-Plate Pcp Assay	Solarcare Technologies Corp,Inc.	LCM	Unclassified	1992-12-11
K924660	Tracheostomy Tube and Tube Cuff	Applied Medical Resources Corp	JOH	Class II	1992-12-11
K924347	Waters(tm) 996 Pda	EMD Millipore Corporation	KIE	Class I	1992-12-11
K923844	Lyris 100/120 Laboratory Information System	Biovation, Inc.	JJQ	Class I	1992-12-11
K922458	Dried Gram-Negative and Positive Mic/combo Panels	Baxter Healthcare Corporation	JWY	Class II	1992-12-11
K922339	Suture Removal Kit	Transidyne General Corp.	MCZ	Class I	1992-12-11
K922303	M-Link	Medimage, Inc.	KPS	Class II	1992-12-11
K922228	2Nd Skin Sterile Adhesive Strip	Spenco Medical Corp.	KGX	Class I	1992-12-11
K921920	Soft-Temp	Adroit Medical Systems, Inc.	DWJ	Class II	1992-12-11
K920977	Meritrans(tm) Disposable Transducer	Merit Medical Systems, Inc.	DRS	Class II	1992-12-11
K920876	Cut Resistant Gloves or Surgical Glove Liner	Medtech Intl., Inc.	KGO	Class I	1992-12-11
K920056	Pocket Size Fetal Heart Detector	Medical Accessories, Inc.	KNG	Class II	1992-12-11
K915301	Advance Stopcock/high Pressure Stopcock	Advance Medical Designs Inc	DTL	Class II	1992-12-11
K913097	Sam St	Ferguson Medical	BTI	Class II	1992-12-11
K924600	Integral Drainage/ventricular/lumbar Drainage Sets	Cordis US Corp.	JXG	Class II	1992-12-10
K924188	Bi-Tech I Bipolar Coagulator/cutting System	Valley Forge Scientific Corp.	GEI	Class II	1992-12-10
K924126	Eub-405	FUJIFILM Healthcare Americas Corporation	IYO	Class II	1992-12-10