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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 927 of 3530

510(k) clearances, page 927 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111132	Genesys Spine Anterior Cervical Plate System	Genesys Spine	KWQ	Class II	2011-12-09
K102494	The Buzz Facial Toning System	Daka International Limited	NFO	Class II	2011-12-09
K113309	Exactech Equinoxe Cage Glenoids	Exactech, Inc.	KWS	Class II	2011-12-08
K113227	Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter	Baxter Healthcare Corporation	FPB	Class II	2011-12-08
K113111	Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion	Inovo, Inc.	NFB	Class II	2011-12-08
K112991	Modified Rog Suture Anchor	Rog Sports Medicine, Inc.	MBI	Class II	2011-12-08
K112533	Zavation Cervical Plate System	Zavation	KWQ	Class II	2011-12-08
K112208	Intutive Surgical Da Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2011-12-08
K112093	Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter	Keeler Instruments, Inc.	HRN	Class II	2011-12-08
K111853	Angled Tapered Abutment	ZimVie US Corp LLC	NHA	Class II	2011-12-08
K111736	Tuttnauer Ez Plus Series Electronic Tabletop Autoclaves	Tuttnauer Ltd.	FLE	Class II	2011-12-08
K111651	Split Cath III	Medical Components, Inc.	MSD	Class II	2011-12-08
K111646	Aspire Cr for Mammography System (Crm); Fcr Aspire Crn (Reader). Note for General Radiography, Reader Is Carbon Xl2/fcr	FUJIFILM Healthcare Americas Corporation	MUE	Class II	2011-12-08
K111310	Brux Mouthguards	Dental Arte, Inc.	OBR	Unclassified	2011-12-08
K111123	Varilift Cervical Interbody Fusion System	Wenzel Spine	ODP	Class II	2011-12-08
K110926	Bone Plate; Bone Screw	Biomaterials Korea Inc.	JEY	Class II	2011-12-08
K110379	Air-N-Go	Satelec	EFB	Class I	2011-12-08
K110325	Aqua Lube	Mayer Laboratories	NUC	Class II	2011-12-08
K110068	Model Pm3030	Omron Healthcare Co., Ltd.	NUH	Class II	2011-12-08
K103103	Presson Electrode	Persyst Development LLC	GXZ	Class II	2011-12-08
K093477	Shield Kyphoplasty System	Soteira, Inc.	NDN	Class II	2011-12-08
K113182	Edwards Lifesciences Intraclude Intra-Aortic Catheter	Edwards Lifesciences LLC	DXC	Class II	2011-12-07
K113179	Acuson Sc2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound di	IYN	Class II	2011-12-07
K113061	Large/extra Lagre Condom	Karex Industries Sdn Bhd	HIS	Class II	2011-12-07
K112597	Seity 37% Phosphoric Acid Etchant Gel	Mycone Dental Supply Co., Inc.	KLE	Class II	2011-12-07
K112489	Swift Fx Bella	ResMed Corp	BZD	Class II	2011-12-07
K112479	Dsj Massager	MEGO AFEK AC Ltd.	IRP	Class II	2011-12-07
K111483	Joule Clearsense Laser System	Sciton, Inc.	PDZ	Class II	2011-12-07
K110924	Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps	Synergetics Inc	GEI	Class II	2011-12-07
K110698	Nuzone X2t Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder Free	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	2011-12-07
K110457	3M Tegaderm Matrix Dressing	3M Company	FRO	Unclassified	2011-12-07
K110364	Dornier Medilas D Litebeam+ 1470	Dornier Medtech America, Inc.	GEX	Class II	2011-12-07
K110046	Athena Pedicle Screw System	Royal Oak Medical Devices	NKB	Class II	2011-12-07
K103544	Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D	Agamatrix	NBW	Class II	2011-12-07
K113404	Dental 3D Planning Software	Symbyo Dental, LLC	LLZ	Class II	2011-12-06
K113011	Spartan S3 Facet System	Spinal Elements, Inc	MRW	Unclassified	2011-12-06
K112565	Novaport One Vascular Access Cannula	Novalung GmbH	DWF	Class II	2011-12-06
K112485	H-Wave	Electronic Waveform Lab, Inc.	GZJ	Class II	2011-12-06
K111889	Zimmer Dental Tapered Screw-Vent M Implant	ZimVie US Corp LLC	DZE	Class II	2011-12-06
K111834	Disco Subtalar Implant	Trilliant Surgical LLC	HWC	Class II	2011-12-06
K111637	Infrared Ear Thermometer	Radiant Innovation Inc.	FLL	Class II	2011-12-06
K111363	Ppx Reagent, Ppx Calibrators, Ppx Qc Material	Medica Corp.	JXN	Class II	2011-12-06
K110700	Ascension Atlas Humeral Plating System	Ascension Orthopedics, Inc.	HRS	Class II	2011-12-06
K113501	Ameditech Checkcup Multi Drug Test (Flat/round Cup)	Ameditech, Inc.	DIO	Class II	2011-12-05
K113350	Brivo Nm 615	GE Healthcare	KPS	Class II	2011-12-05
K113213	Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued from Line 2	Biosense Webster Inc	DRF	Class II	2011-12-05
K112845	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2011-12-05
K112832	Eye Care Cure Contact Lens Case	Eye Care and Cure	LRX	Class II	2011-12-05
K112610	Synthetic Vinyl Examination Gloves, Powder Free (and Multiple Labels)	Inpro Technology Device Factory	LYZ	Class I	2011-12-05
K112592	Axle Peek Interspinous Fusion System	Xtant Medical Holdings, Inc.	KWP	Class II	2011-12-05