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 860 of 3530

510(k) clearances, page 860 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122784	Ness L300 System Kit, Lef Model Lg3-5100; Ness L300 System Kit, Right Model Lg3-5000; Small Ness L300 System Kit, Right	Bioness, Inc.	GZI	Class II	2012-12-27
K122749	Prestige-Mobie	Prestige Sporting Goods Co., Ltd.	INI	Class II	2012-12-27
K122134	Flexlite Camera	Spine View, Inc.	HRX	Class II	2012-12-27
K122039	Kingscross Pl-C+b-10, Kingscross Pl-C+b-12, Kingscross Pl-C+b-08, Kingscross B	Kettenbach GmbH & Co KG	EBG	Class II	2012-12-27
K121710	Xpert Ct/ng	Cepheid	LSL	Class II	2012-12-27
K121693	A-Wedge Anterior Interbody System (a-Wedge Ais)	Sapphire Medical Group	MAX	Class II	2012-12-27
K121661	Ez-Assist-Fill	Assist Fill, LLC	PCM	Class I	2012-12-27
K121653	Intrabeam System with Intrabeam Spherical Applicators	Carl Zeiss Meditec Inc	JAD	Class II	2012-12-27
K121549	Non-Sterile, Powder-Free Nitrile Examination Glove, Blue	Siam Sempermed Corp., Ltd.	LZA	Class I	2012-12-27
K120490	Quick Sampler Holder	Nipro Medical Corporation	JKA	Class II	2012-12-27
K123017	Sterrad Cyclesure 24 Biological Indicator Model 14324	Advanced Sterilization Products	FRC	Class II	2012-12-26
K123836	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. dba Angiotech	GAM	Class II	2012-12-21
K123773	X-Tra Base	Voco GmbH	EBF	Class II	2012-12-21
K123771	Kyphon Express II Inflatable Bone Tamps	Medtronic, Inc.	HRX	Class II	2012-12-21
K123754	Cx50 3.0 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2012-12-21
K123729	Versarate Flow Rate Controler	Emed Technologies Corporation	FPA	Class II	2012-12-21
K123669	Transtek Wrist Blood Pressure Monitor	Zhongshan Transtek Electronics Co., Ltd	DXN	Class II	2012-12-21
K123637	Hamilton-C3	Hamilton Medical AG	CBK	Class II	2012-12-21
K123616	Portable Ultrasonic Diagnostic System	Sonoscape Company Limited	IYO	Class II	2012-12-21
K123611	E-Cube 7	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2012-12-21
K123341	Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button	Arthrex GmbH	MBI	Class II	2012-12-21
K123260	Detachatip III	ConMed Corporation	GEI	Class II	2012-12-21
K123191	Xpert Flu	Cepheid	OCC	Class II	2012-12-21
K123172	Kogent Bipolar Forceps	Katalyst Surgical, LLC	GEI	Class II	2012-12-21
K123092	Ceramin Brackets Z	Tomy, Inc.	NJM	Class II	2012-12-21
K123000	Integra Total Foot Systems	Integra LifeSciences Corporation	HRS	Class II	2012-12-21
K122961	Wondfo Amphetamine Urine Test (Amp 300), Wondfo Methamphetamine Urine Test (Met 500)	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2012-12-21
K122948	Gem-Stim Combo Stimulator	Gemore Technology Co., Ltd.	GZJ	Class II	2012-12-21
K122944	Gemore True Sine Interferential Stimulator	Gemore Technology Co., Ltd.	LIH	Class II	2012-12-21
K122897	Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645	Invivo Corporation	MOS	Class II	2012-12-21
K122717	Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask	Tiger Medical Products, Ltd.	FXX	Class II	2012-12-21
K122690	Ultraquik Peripheral Nerve Block Needle	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	Class II	2012-12-21
K122616	Panther Ois/r & V Model Version 2.0	Prowess, Inc.	IYE	Class II	2012-12-21
K122609	Vasculaire Compression System Model Fls-0003; Vasculaire Sleeve (Foot & Calf) Model Fls-0002; Vasculaire Sleeve (Calf) F	Venous Health Systems, Inc.	JOW	Class II	2012-12-21
K122414	Ab Command Dual Channel Fitness Belt	Leto Enterprises Incorporation	NGX	Class II	2012-12-21
K122142	Glooko Logbook Charts	Glooko Inc	NBW	Class II	2012-12-21
K122106	Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle	Veran Medical Technologies, Inc.	JAK	Class II	2012-12-21
K121555	Centurion Vision System	Alcon Laboratories	HQC	Class II	2012-12-21
K121077	Nhancer	IMDS Operations B.V.	DQY	Class II	2012-12-21
K121003	Abbott Plex-Id Flu Assay	Abbott Medical	OCC	Class II	2012-12-21
K120948	Prexion 3D	The Yoshida Dental Mfg. Co., Ltd.	OAS	Class II	2012-12-21
K120822	Straumann Cares Variobase Abutment Nnc, Straumann Cares Variobase Abutment Rn, Straumann Cares Variobase Abutment Wn, St	Straumann USA, LLC	NHA	Class II	2012-12-21
K120793	Z-Look3 Evo Slm	Z-Systems AG	DZE	Class II	2012-12-21
K120475	Anesthesia Conduction Needles	Shanghai Samedical & Plastic Instruments Co., Ltd.	BSP	Class II	2012-12-21
K120391	Mr4500 Wheelchair	Wardray Premise Ltd	IOR	Class I	2012-12-21
K113023	Streamline Airless System Set with Pre-Attached Dialyzer	NxStage Medical Inc	KDI	Class II	2012-12-21
K113010	Fdes100(tens and Ems Stimulator, Fdes102(ed402) TENS Stimulator	Famidoc Technology Co., Ltd	IPF	Class II	2012-12-21
K112898	Delta Tt Cups, Delta Tt Liners, Bone Screws	Lima Corporate S.p.A.	LPH	Class II	2012-12-21
K123659	Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)	Actuated Medical, Inc.	KNT	Class II	2012-12-20
K123585	Syngo, CT Cardiac Function	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-12-20