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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 591 of 3529

510(k) clearances, page 591 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171020	Arthrex Knotless SutureTak Anchor	Arthrex GmbH	MBI	Class II	2017-05-16
K170680	TEVADAPTOR Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	ONB	Class II	2017-05-16
K170575	Disposable Powder Free Vinyl Exam Glove, Clear/Yellow	Ever Global (Vietnam) Enterprise Corporation	LYZ	Class I	2017-05-16
K170500	SIROLaser Advance+	Dentsply Sirona Inc	GEX	Class II	2017-05-16
K170496	Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory	Stryker Corp.	NKB	Class II	2017-05-16
K170481	Strep B Carrot Broth Kit	Hardy Diagnostics	PQZ	Class I	2017-05-16
K170462	KARL STORZ ShuntScope	Karl Storz Endoscopy-America, Inc.	GWG	Class II	2017-05-16
K170338	A-View	Stroke2prevent B.V.	ITX	Class II	2017-05-16
K170245	DSM Biomedical Dental Bone Graft	Kensey Nash Corporation dba Dsm Biomedical	NPM	Class II	2017-05-16
K163701	Direxion and Direxion HI-FLO Torqueable Microcatheters	Boston Scientific Corporation	KRA	Class II	2017-05-16
K163502	iSR'obot Biopsy Kit	Biobot Surgical Pte. Ltd.	ITX	Class II	2017-05-16
K163226	EPIC Extremely Small Staple	Epic Extremely, LLC	JDR	Class II	2017-05-16
K163181	TRANSLACE™ Spinal Tethering System	Medtronic Sofamor Danek USA Inc	OWI	Class II	2017-05-16
K163002	Kangaroo Feeding Tube with IRIS Technology	Covidien (dba Medtronic)	KNT	Class II	2017-05-16
K162133	VerteFIT Corpectomy Cage System	Ldr Spine USA	MQP	Class II	2017-05-16
K171137	Evs 2430W, Evs 2430Gw	DRTECH Corporation	MQB	Class II	2017-05-15
K170784	Pneumoclear	Novanta Medical GmbH	HIF	Class II	2017-05-15
K170370	Ultrashape Power System	Syneron Medical, Ltd.	OHV	Class II	2017-05-15
K170312	IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools	Medtronic Powered Surgical Solutions	HBC	Class II	2017-05-15
K170023	SPiN Thoracic Navigation System	Veran Medical Technologies, Inc.	JAK	Class II	2017-05-15
K163638	Dental 5 Multi Diode laser	Bio-Med USA, Inc.	GEX	Class II	2017-05-15
K163557	SS SA Fixture	OSSTEM Implant Co., Ltd.	DZE	Class II	2017-05-15
K153410	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing	3M Company	SEL	Unclassified	2017-05-15
K162333	Wondfo One Step Fecal Occult Blood (FOB) Test	Guangzhou Wondfo Biotech Co., Ltd.	KHE	Class II	2017-05-14
K171119	Gm85	Samsung Electronics Co., Ltd.	IZL	Class II	2017-05-12
K171083	iChemVELOCITY Automated Urine Chemistry System	Iris Diagnostics, A Division of Iris International, Inc.	JIL	Class II	2017-05-12
K171072	N Latex Cystatin C; N Protein Standard UY	Siemens Healthcare Diagnostics Products Limited	NDY	Class II	2017-05-12
K170401	Piccolo Composite® Plate System	CarboFix Orthopedics Inc.	HRS	Class II	2017-05-12
K170228	Belimed Steam Sterilizer MST-H TOP 5000	Belimed AG	FLE	Class II	2017-05-12
K170199	Unity Network ID	GE Healthcare	MWI	Class II	2017-05-12
K162392	Avazzia	Avazzia, Inc	NUH	Class II	2017-05-12
K161261	Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase	GENEA BIOMEDX Pty Ltd.	MQL	Class II	2017-05-12
K171085	Gmr40	Neurologica Corporation, A Subsidiary of	MQB	Class II	2017-05-11
K170990	Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator	Spiration, Inc.	GEI	Class II	2017-05-11
K170679	CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems	Medtronic Sofamor Danek	NKB	Class II	2017-05-11
K170648	ANTHEM CR Total Knee System	Smith & Nephew, Inc.	JWH	Class II	2017-05-11
K170647	Connector System	Orthofix SRL	NKG	Class II	2017-05-11
K170584	Mako Partial Knee Application	Mako Surgical Corp.	OLO	Class II	2017-05-11
K170581	Mako Total Knee Application	Mako Surgical Corp.	OLO	Class II	2017-05-11
K170491	Solana C. difficile Assay	Ortho-Clinical Diagnostics, Inc.	OZN	Class II	2017-05-11
K170419	SurgiCase Viewer	Materialise N.V.	LLZ	Class II	2017-05-11
K170413	BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set	Bio-Rad Laboratories Inc.	LIP	Class II	2017-05-11
K170382	Arthrex Compression Screws	Arthrex GmbH	HWC	Class II	2017-05-11
K170205	Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203	Shenzhen Kentro Medical Electronics Co., Ltd	NUH	Class II	2017-05-11
K170135	TREFOIL System	Nobel Biocare AB	DZE	Class II	2017-05-11
K163622	Lung Vision	Bodyvision Medical, Ltd.	LLZ	Class II	2017-05-11
K163576	GORE SYNECOR Preperitoneal Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	2017-05-11
K163276	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-05-11
K163250	Longitudinal Brain Imaging (LoBI) application	Philips Medical Systems Nederland B.V.	LLZ	Class II	2017-05-11
K163131	A-dec NLZ Electric Motor System	Nakanishi Inc.	EBW	Class I	2017-05-11