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 950 of 3531

510(k) clearances, page 950 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110468	Freeway Comfort Bite Guard	Randmark Dental Products, LLC	MQC	Unclassified	2011-08-05
K110204	Brainlab Trauma	Brainlab, Inc.	OLO	Class II	2011-08-05
K110027	Surgical Face Mask; Surgical Face Mask	Angeline Group Ltd.	FXX	Class II	2011-08-05
K101517	Sedecal Mobile Digital Diagnostic X-Ray	Sedecal S.A.	IZL	Class II	2011-08-05
K100967	Perimeter C Spinal System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2011-08-05
K111911	Corin Optimom Modular Head	Corin USA	KWL	Class II	2011-08-04
K111677	Microscan(r) Microstrep Plus(r)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2011-08-04
K111478	Stryker Spine Power Adaptor (Accessory Instrument)	Stryker Corp.	NKB	Class II	2011-08-04
K111387	Liat (Tm) Influenza a / B Assay, Liat (Tm) Analyzer	Iquum, Inc.	OCC	Class II	2011-08-04
K111372	Tal Pallindrome (Tm) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (Tm) Dual Lumen Catheter, Palindrome (Tm)...	Medtronic, Inc.	MSD	Class II	2011-08-04
K111122	Aesculap Sibd Xp Spinal System	Aesculap Inc	OVD	Class II	2011-08-04
K111043	Atlantis Sr Pro2 Coronary Imaging Catheter, Icross Coronary Imaging Catheter	Boston Scientific Corporation	OBJ	Class II	2011-08-04
K110410	Ms-120Bk Electric Stimulator (Extension Unit)	Nihon Kohden Corp.	GYC	Class II	2011-08-04
K110245	United Utf Stem	United Orthopedic Corp.	LPH	Class II	2011-08-04
K110005	Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8Fr Tube	Syncro Medical Innovations, Inc.	KNT	Class II	2011-08-04
K112072	Atricure Cryo Module System	AtriCure, Inc.	GEH	Class II	2011-08-03
K111705	Ekosonic Endovascular System	Ekos Corp.	QEY	Class II	2011-08-03
K111527	Multicode-Rtx Herpes Simplex Virus 1 & 2 Kit	Eragen Biosciences	OQO	Class II	2011-08-03
K111376	Construx External Fixation Device	Ebi, LLC	KTT	Class II	2011-08-03
K111195	Valutrus Reusable Circular Stapler and Disposable Reloads	Ethicon Endo-Surgery Inc	GDW	Class II	2011-08-03
K111095	Breeze Electric Transport Chair Model 1025	Electro Kinetic Technologies, LLC	ITI	Class II	2011-08-03
K110735	Tanda Max OTC System	Pharos Life Corporation	OHS	Class II	2011-08-03
K110707	Care Back Pain Relief Stimulator; Care Back Pain Relief Stimulator	Shenzhen Dongdixin Technology Co., Ltd.	NUH	Class II	2011-08-03
K110350	Kneehab Xp	Bio-Medical Research, Ltd.	GZJ	Class II	2011-08-03
K103796	Telemedcare Health Monitor	Telemedcare Pty, Ltd.	DRG	Class II	2011-08-03
K102760	Atlas Home Pregnancy Test (Midstream Format) Model 70172001	Atlas Medical	LCX	Class II	2011-08-03
K101934	Dynnail, 12Mm, Locking Screw, 4.6 Mm, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46Xx, 2200-01-0000	Medshape, Inc.	HSB	Class II	2011-08-03
K111675	Vu C*pod Intervertebral Body Fusion Device	Theken Companies LLC	ODP	Class II	2011-08-02
K111288	Anchorwire Guidewire	Lake Region Medical	DQX	Class II	2011-08-02
K111253	Arthrex Distal Extremity Plate System	Arthrex GmbH	HRS	Class II	2011-08-02
K111067	Jie+hong Medical Surgical Gowns - Sterile, Jie+hong Medical Surgical Gowns - Non Sterile	Kunshan Jiehong Nonwoven Product Co., Ltd.	FYA	Class II	2011-08-02
K110991	Mesa Spinal System (Keystone Rods)	K2M, Inc	MNI	Class II	2011-08-02
K110858	Lo-Bak Trax	Roland F Berthiaume, DC	HST	Class I	2011-08-02
K110801	Wv3000t Digital X-Ray Direct Imaging Flat Panel Detector System	Direct Digital Imaging Technology (Beijing), Inc.	MQB	Class II	2011-08-02
K110679	Del Mar Monoaxial Pedicle Screw System	Phygen, LLC	NKB	Class II	2011-08-02
K103802	Trusignal R Spo2 Peditip Sensor; Trusignal R Spo2 Peditip Sensor; Trusignal R Spo2 Peditip Sensor	GE Healthcare Finland Oy	DQA	Class II	2011-08-02
K103733	United U2 Xpe Total Knee System	United Orthopedic Corp.	JWH	Class II	2011-08-02
K102489	Vantage Titan 3T	Toshiba Medical Systems Corporation, Japan	LNH	Class II	2011-08-02
K102158	Sigma Sterilization Pouch & Roll	Sigma Medical Supplies Corp.	FRG	Class II	2011-08-02
K111808	Sonolith I-Move	EDAP TMS France SA	LNS	Class II	2011-08-01
K111745	King of Hearts Express Af Cardiac Event Recorder	Card Guard Scientific Survival, Ltd.	DSH	Class II	2011-08-01
K111686	A & D Medical Ua-1000 Family Dagital Blood Pressure Monitors	A&D Company, Ltd.	DXN	Class II	2011-08-01
K111431	B1p Adhesive	Pentron Clinical	KLE	Class II	2011-08-01
K111395	Primewire Prestige Plus	Volcano Corporation	DQX	Class II	2011-08-01
K111334	Benelli Access Device	Vascular Solutions LLC	DQY	Class II	2011-08-01
K111160	Intricon Datrix Centauri Mt Ambulatory Patient ECG Telemetry System (Apets)	Intricon Datrix Corporation	DSI	Class II	2011-08-01
K110958	Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet Footswitch	Smith & Nephew, Inc.	FQH	Class II	2011-08-01
K110653	Cure Catheter	Cure Medical, LLC	EZD	Class II	2011-08-01
K110383	Babi*plus Pressure Relief Manifold - 10Cm H20, 12.5Cm H20, 15Cm H20	A Plus Medical	BZD	Class II	2011-08-01
K102400	Syphilis Health Check	Diagnostics Direct LLC	LIP	Class II	2011-08-01