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 2026-11-02, 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 971 of 3531

510(k) clearances, page 971 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103425	Zen-7000, Fluoroscopic X-Ray System	Genoray America Inc.	OWB	Class II	2011-03-29
K103038	Duet Drf	CMT Medical Technologies, Ltd.	JAA	Class II	2011-03-29
K103026	Electro Sensor -Body Composition	LD Technology LLC	MNW	Class II	2011-03-29
K101530	Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D	Cook Ireland Ltd.	MUM	Class II	2011-03-29
K110686	Accutrac	Boston Scientific Corporation	GEX	Class II	2011-03-28
K110050	Fit Test C&b	Voco GmbH	ELW	Class II	2011-03-28
K110036	Fx 222-02 Powered Wheelchair	Lanzhou Wanli Aviation Electromechanical, Inc.	ITI	Class II	2011-03-28
K102874	New Stetic Acrylics	New Stetic	EBI	Class II	2011-03-28
K102521	Pantino Pro Positiner	Somnomed Inc.	LRK	Class II	2011-03-28
K101154	Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-L	Airsep Corp.	CAW	Class II	2011-03-28
K093987	Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2kun6	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2011-03-28
K110699	Ligamax 5	Ethicon Endo-Sugery, LLC	FZP	Class II	2011-03-25
K110585	Captiva Spine Fuselox Cervical Cage	CAPTIVA SPINE, Inc.	ODP	Class II	2011-03-25
K110526	Zoll Aedpro with 2010 Aha Guidelines Software Update	ZOLL Medical Corporation	MKJ	Class III	2011-03-25
K110385	Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter	Ethicon Endo-Surgery Inc	GDW	Class II	2011-03-25
K103551	Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits,	Baxter Healthcare Corporation	FPA	Class II	2011-03-25
K103389	Truclear Incisor Plus Blade 2.9	Smith & Nephew, Inc.	HIH	Class II	2011-03-25
K103237	Lanx Spinal System	Lanx, Inc.	NKB	Class II	2011-03-25
K103105	Orthodontic Screw	OSSTEM Implant Co., Ltd.	OAT	Class II	2011-03-25
K102640	Vertex Self Curing, Vertex Castavaria, Vertex Castapress	Vertex-Dental B.V.	EBI	Class II	2011-03-25
K102578	Apex Ps Knee System	Omni Life Science, Inc.	JWH	Class II	2011-03-25
K102275	Thermedx 37-5 Electrocautery Probes, Models Mpj200, Mpj210, Mps220, Mpn230, Bph240	Thermedx LLC	GEI	Class II	2011-03-25
K102196	Computed Tomography X-Ray System	Vatech Co., Ltd.	OAS	Class II	2011-03-25
K101971	Syntec Os Spinal Fixation System	Syntec Scientific Corp.	NKB	Class II	2011-03-25
K101560	Medline Retractable Safety Syringe	MEDLINE INDUSTRIES, LP - Northfield	MEG	Class II	2011-03-25
K110555	Arcomxl Active Articulation	Biomet Manufacturing Corp	LPH	Class II	2011-03-24
K110416	Abl835 Flex Analyzer with Pleural Ph	Radiometer Medical ApS	CHL	Class II	2011-03-24
K110332	Clearcanvas Ris / Pacs	Clearcanvas, Inc.	LLZ	Class II	2011-03-24
K110054	Navitrack System - Os Knee Universal, Cas Same Incision Tibia Reference	Zimmer CAS	OLO	Class II	2011-03-24
K110042	Manukatex	Manuka Medical Limited	FRO	Unclassified	2011-03-24
K103837	Balanced Knee System Revision Offset Tibia	Ortho Development Corp.	JWH	Class II	2011-03-24
K103786	Zest Petite Nasal Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2011-03-24
K103656	Thermo Scientific Mas R Doa Total	Microgenics Corporation	DIF	Class I	2011-03-24
K103427	Mobileecg System	Memtec Corp.	DPS	Class II	2011-03-24
K103395	Performax Total Face Mask	Respironics, Inc.	BZD	Class II	2011-03-24
K103170	Gmk Revision Knee Sc Liners	Medacta International SA	JWH	Class II	2011-03-24
K102677	Bodytom Nl 4000	Samsung HME America, Inc.	JAK	Class II	2011-03-24
K102647	Elitech Clinical Systems Selectra Prom/elical 2/Elitrol I and Elitrol Ii/ast/got 4+1 Sl/potassium, Sodium, Chloride...	Elitechgroup Vital Scientific BV	JGS	Class II	2011-03-24
K102465	BIPAP Avaps Ventilatory Support System	Respironics, Inc.	MNS	Class II	2011-03-24
K101721	Well Lead Tracheostomy Tube and Disposable Inner Cannula	Regulatory & Marketing Services, Inc.	BTO	Class II	2011-03-24
K094035	Exp Acetabular Liner, Models Sc3342 Non-Hooded 28Mm, Sc3343 Hooded 28Mm	Globus Medical, Inc.	OQG	Class II	2011-03-24
K110552	Valor(r) Ankle Fusion Nail System Screw	Wrightmedicaltechnologyinc	HSB	Class II	2011-03-23
K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	OUR	Class II	2011-03-23
K110367	Pioneer Spinal Process Fusion Plate	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	Class II	2011-03-23
K103666	Lanx Lateral	Lanx, Inc.	MAX	Class II	2011-03-23
K103661	Rubbercare Powder Free Nitrile Examination Glove	Rubbercare Protection Products Sdn Bhd	LZA	Class I	2011-03-23
K103650	Non-Sterile, Powder-Free, Blue Latex Examination Gloves, without Bubble Gum or Grape Scent,w/ Protein Content Claim	Oon Corp. Resources	LYY	Class I	2011-03-23
K103245	Celstat	Baxter Healthcare Corporation	QSY	Unclassified	2011-03-23
K103111	Forza Spacer System	Orthofix SRL	MAX	Class II	2011-03-23
K102241	Anthogyr Implanteo Implantology and Dental Surgical Motor Unit	Anthogyr SAS	EBW	Class I	2011-03-23