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 999 of 3531

510(k) clearances, page 999 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102435	Beyondimage Workstation	Neusoft Medical Systems Co., Ltd.	LLZ	Class II	2010-10-15
K102331	Ldr Spine USA Spinetune Tl Spinal System	Ldr Spine USA	MNI	Class II	2010-10-15
K102024	Rpm Respiratory Gating System	Varian Medical Systems, Inc.	IYE	Class II	2010-10-15
K101955	St Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058	Abbott Medical	DRF	Class II	2010-10-15
K101811	Protegrity Smt Latex Surgicalgloves	Medtronic, Inc.	KGO	Class I	2010-10-15
K101351	Non-Sterile Powder- Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent	Ascend Eagle, Inc.	LZA	Class I	2010-10-15
K093833	Kapss Spinal System	Robert Reid Inc.	MNI	Class II	2010-10-15
K093547	Pinpointe Footlaser	Pinpointe USA, Inc.	PDZ	Class II	2010-10-15
K093545	Pinpointe Footlaser Model 6W, 30W, 100W	Incisive, Inc. (Formerly Named Incisive, LLC)	GEX	Class II	2010-10-15
K092274	Randox Benzodiazepine Assay	Randox Laboratories, Limited	JXM	Class II	2010-10-15
K101864	Kyphon Xpander II Inflatable Bone Tamp	Medtronic, Inc.	HRX	Class II	2010-10-14
K101848	Sapphire Anterior Cervical Plate System	Spinal Elements, Inc	KWQ	Class II	2010-10-14
K093562	Endosseous Dental Implant	Southern Implants, (Pty.) Ltd.	DZE	Class II	2010-10-14
K092593	Provox Activalve (Size 4.5Mm, 6Mm, 8Mm, 10Mm, 12.5Mm)	Atos Medical AB	EWL	Class II	2010-10-14
K102325	Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)	Covidien, LLC, Formerly Registered AS Tyco Healthca	GDW	Class II	2010-10-13
K102041	Aixplorer	Supersonic Imagine	ITX	Class II	2010-10-13
K101859	Rel-K Artifical Limb Prosthesis	Rizzoli Ortopedica S.p.A.	ISY	Class I	2010-10-13
K101518	Compass Vascular Access; Compass Lumbar Puncture	Mirador Biomedical, Inc.	DRS	Class II	2010-10-13
K101271	Hemostasis Management System Plus (Hms Plus ), Model 305 Xx	Medtronic, Inc.	JOX	Class II	2010-10-13
K101149	Ge Vivid E9 Diagnostic Ultrasound Imaging System	GE Vingmed Ultrasound AS	IYO	Class II	2010-10-13
K100593	Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme	Lsi Solutions Inc.	GAW	Class II	2010-10-13
K100310	Btl-08 ECG Recorder Model Btl-08 ECG Lc Plus, Btl-08 ECG Lt Plus	BTL Industries, Inc	MWJ	Class II	2010-10-13
K094060	Quanta Flash H-Ttg Iga	Inova Diagnostics, Inc.	MVM	Class II	2010-10-13
K093093	Small Plateau Spacer System	Life Spine	ODP	Class II	2010-10-13
K102671	Syngo Rt Therapist Connect Workspace, V4.2	Siemens Medical Solutions USA, Inc.	IYE	Class II	2010-10-12
K102000	Imagys	Keosys SAS	LLZ	Class II	2010-10-12
K101987	Cool Line Catheter, Model Cl-2295A, Icy Catheter, Model Ic-3893A and Quattro Catheter, Model Ic-4593	ZOLL Circulation, Inc.	NCX	Class II	2010-10-12
K101700	Io Fix Hand, Io Fix Foot, Extremity Medical Screw System	Extremity Medical, LLC	HWC	Class II	2010-10-12
K100580	Exsalt Wound Dressing	Exciton Technologies Inc.	FRO	Unclassified	2010-10-12
K100071	Emcoolspad	Emcools Emergency Medical Cooling Systems AG	NZE	Class II	2010-10-12
K102608	Securmark Biopsy Site Marking System	Suros Surgical Systems, Inc. A Hologic Company	NEU	Class II	2010-10-08
K102450	Ionolux Pro	Voco GmbH	EBF	Class II	2010-10-08
K102161	Blue Sail Innovation	Shandong Blue Sail Innovation Co Ltd	LYZ	Class I	2010-10-08
K102071	Ostene CT, Aoc CT, Osteotene, Ceretene	Ceremed, Inc.	MTJ	Unclassified	2010-10-08
K102059	Autoclavable Camer Head Model Otv-Y0017	Olympus Medical Systems Corp.	FET	Class II	2010-10-08
K101787	Duolink II	Bisco Inc	EMA	Class II	2010-10-08
K101670	United U2 Bipolar Implant	United Orthopedic Corp.	KWY	Class II	2010-10-08
K101594	Powder Free Nitrile Patient Examination Gloves, Blue	Better Care Plastic Technology Cp., Ltd.	LZA	Class I	2010-10-08
K101331	Labsystem Pro Ep Recording System V3.1 Software	C.R. Bard Inc., Bard Electrophysiology Division	DQK	Class II	2010-10-08
K101177	Apexnrg Rider	Medicnrg, Ltd.	LQY	Unclassified	2010-10-08
K101096	Ht III Sa Fixture System	Hiossen, Inc.	DZE	Class II	2010-10-08
K100653	Jet Xr Radiopaque Acrylic Resin Powder 45 Grams, Jet Xr Radiopaque Acrylic Resin Powder 100 Grams, Jet Liquid 118 Ml Mod	Lang Dental Mfg Co, Inc.	EBI	Class II	2010-10-08
K100011	Fisher & Paykel Healthcare Bubble CPAP System	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2010-10-08
K092407	Remel Spectra Mrsa	Remel Inc	JSO	Class II	2010-10-08
K102728	Arstasis Access System	Arstasis, Inc.	DYB	Class II	2010-10-07
K102632	Ethicon Endo-Surgery 5Mm Laparoscopic Multi-Feed Stapler	Ethicon Endo-Surgery Inc	GDW	Class II	2010-10-07
K102604	I-Logic Inreach System	Medtronic, Inc.	JAK	Class II	2010-10-07
K102582	Arterioflow Model 7500 Sequential Compression Device	Devon Medical, Inc.	JOW	Class II	2010-10-07
K102556	Volpara, Version 1.3	Matakina Technology Limited	LLZ	Class II	2010-10-07
K102529	D2rf Digital Dynamic Remote System	Stephanix Radiological Systems	OWB	Class II	2010-10-07