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 955 of 3531

510(k) clearances, page 955 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110541	Figure 8 Sternotomy Closure Device	Figure 8 Surgical, Incorporated	JDQ	Class II	2011-07-06
K110280	Revlok Fenestrated Screw System	Globus Medical, Inc.	NKB	Class II	2011-07-06
K092688	Fora Poct S10/td-4258 Blood Glucose Monitoring System	Taidoc Technology Corporation	LFR	Class II	2011-07-06
K111596	Total Shoulder System	SHOULDER INNOVATIONS, Inc	KWS	Class II	2011-07-05
K111259	Sv Dbs Vrain Array	Midwest Rf, LLC	MOS	Class II	2011-07-05
K111215	Ascom Mobile Monitoring Gateway (Mmg)	Ascom Sweden AB	MSX	Class II	2011-07-05
K110925	Novabone Macropor-Si+ - Bioactive Bone Graft	Novabone Products, LLC	MQV	Class II	2011-07-05
K110880	Validate (R) Gc3 Calibration Verification / Linearity Test Kit	Maine Standards Co.	JJY	Class I	2011-07-05
K110809	Wireless Monitoring System	CareFusion 303, Inc	DRG	Class II	2011-07-05
K111546	U2 Hip System	United Orthopedic Corp.	LPH	Class II	2011-07-01
K111226	Endoscout Tracking System	Robin Medical, Inc.	LNH	Class II	2011-07-01
K111179	Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue Suspension System System (Monofilamen	Siesta Medical, Inc.	ORY	Class II	2011-07-01
K111118	Ams Elevate Pc Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite	American Medical Systems, Inc.	OTP	Class III	2011-07-01
K111029	Fora Poct Managment System	Taidoc Technology Corporation	NBW	Class II	2011-07-01
K111025	Trigen Low Profile Bone Screw	Smith & Nephew, Inc.	HSB	Class II	2011-07-01
K110940	Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen	Zimmer GmbH	KRO	Class II	2011-07-01
K110897	Cortex CO2 / Er:yag Laser System	Sandstone Medical Technologies, LLC	GEX	Class II	2011-07-01
K110682	Steritite Container System & Meditray Products	Case Medical, Inc.	KCT	Class II	2011-07-01
K110643	Merit Marquis Flow Switch	Merit Medical Systems, Inc.	DQO	Class II	2011-07-01
K110300	Simplant 2011	Materialise Dental NV	LLZ	Class II	2011-07-01
K103776	Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for Rvp Fast	Luminex Molecular Diagnostics Inc	OCC	Class II	2011-07-01
K103563	Precision Portable Oxygen Concentration Model 4150	Precision Medical, Inc.	CAW	Class II	2011-07-01
K102786	Well-Life OTC Ems System	Well-Life Healthcare Limited	NGX	Class II	2011-07-01
K102719	Atlantean Trigger Nebulizer	Atlantean	CAF	Class II	2011-07-01
K102648	Ant Inflation Device/ant Inflation Device Compact Pack	Shenzhen Ant Hi-Tech Industrial Co., Ltd.	MAV	Class II	2011-07-01
K101306	Sp Dynamis, Sp Spectro, Xs Dynamis, Xs Spectro, Xp Dynamis, Xp Spectro, Models M021-4Af/3, M002-2A	Fotona D.D.	GEX	Class II	2011-07-01
K111674	Acuson	Siemens Medical Solutions USA, Inc.	IYN	Class II	2011-06-30
K111498	Fathom (Tm) 14 Steerable Guidewire	Boston Scientific Corporation	DQX	Class II	2011-06-30
K111488	Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003	Boston Scientific Corporation	DQX	Class II	2011-06-30
K111485	Fathom 16 Steerable Guidewire Model M001509xxx	Boston Scientific Corporation	DQX	Class II	2011-06-30
K111219	Gmd Universal Urinary Incontinence Sling	Generic Medical Device, Inc.	OTN	Class II	2011-06-30
K111148	S8 Aspen with H4i Plus	ResMed Corp	BZD	Class II	2011-06-30
K111117	Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep(r) Retrograde Chronic...	Teleflexmedical, Inc.	MSD	Class II	2011-06-30
K111107	Super Porcelain Ex-3 Universal Opaque	Noritake Co., Inc.	EIH	Class II	2011-06-30
K110967	Enterprise Electrophysiology System	Neuralynx, Inc.	OMC	Class II	2011-06-30
K110886	Clio/cliosoft	Sota Precision Optics, Inc.	LLZ	Class II	2011-06-30
K110839	Scanora 3D	Soredex Palodex Group Oy	OAS	Class II	2011-06-30
K110650	Zyston Arc Interbody Spacer	Biomet Spine (Aka Ebi, LLC)	MAX	Class II	2011-06-30
K103655	Octane-C Interbody Fusion Device System	Exactech, Inc.	ODP	Class II	2011-06-30
K103234	Gc Aadva Bo Ac Abutments	GC America Inc.	NHA	Class II	2011-06-30
K102856	Sirocco Thermal Regulating System	Galmaz Biotech S.L.	DWJ	Class II	2011-06-30
K102813	Ezono 3000	Life-Tech, Inc.	IYN	Class II	2011-06-30
K102573	Provu (Tm) Dental X-Ray System	Advanced Image Science, Inc.	EAP	Class II	2011-06-30
K102177	Sensicare Powder-Free Polymer Coated Polysoprene Surgical Gloves, Sterile	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2011-06-30
K111672	Max Orient Suction Device for Electrocauterizer	Pacific Hospital Supply Co., Ltd	GEI	Class II	2011-06-29
K111046	Corin Minihip Femoral Stem	Corin USA	LZO	Class II	2011-06-29
K110616	Thermo Scientific Mas Omni-Immune, Mas Omni Immune Pro	Microgenics Corporation	JJY	Class I	2011-06-29
K110223	Waveguard (Tm) EEG Cap	Eemagine Medical Imaging Solutions GmbH	GXY	Class II	2011-06-29
K110099	Proclear Toric Xr Soft (Hydrophilic) Contact Lens; Proclear Multifocal Xr Soft (Hydrophilic) Contact Lens; Proclear Mult	CooperVision, Inc.	LPL	Class II	2011-06-29
K103495	Asico Softip Injector System	Asico, LLC	MSS	Class I	2011-06-29