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 908 of 3530

510(k) clearances, page 908 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120206	Medtronic Minimed Paradigm Insulin Pumps	Medtronic, Inc.	LZG	Class II	2012-03-29
K120088	Mcompass Anorectal Manometry System	Medspira, LLC	KLA	Class II	2012-03-29
K120005	Acds	Isopure Corp	KPO	Class II	2012-03-29
K113365	Infant Array	Advanced Imaging Research dba Sree Medical Systems	MOS	Class II	2012-03-29
K113327	Hoffmann Lrf (Limb Reconstruction Frame) System	Stryker Corp.	KTT	Class II	2012-03-29
K113288	Vpap St-a	ResMed Corp	MNS	Class II	2012-03-29
K113233	Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim	Shen Wei (USA), Inc.	KGO	Class I	2012-03-29
K113058	Tiger Spine System	Corelink, LLC	NKB	Class II	2012-03-29
K112863	Enteral Administration Set with Solution Container, Enteral Administration Set, Enteral Extension Set with Minitube Conn	Acta Medical L.L.C.	KNT	Class II	2012-03-29
K112798	Locking Compression Plate System	Shanghai Microport Orthopedics Co., Ltd.	HRS	Class II	2012-03-29
K112702	Imperial Surgical Ltd. Blankey and Solution Warning Cabinets	Imperial Surgical Ltd.	LGZ	Class II	2012-03-29
K112538	Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CHH	Class I	2012-03-29
K111703	Infrared Ear Therometer	Fudakang Industrial Co Ltd	FLL	Class II	2012-03-29
K110737	Rightest Blood Glucose Monitoring System Gm700	Bionime Corporation	NBW	Class II	2012-03-29
K120630	Azur Detachable 18	Terumo Cardiovascular Systems Corporation	KRD	Class II	2012-03-28
K120576	Zavation Ibf System	Zavation	MAX	Class II	2012-03-28
K120123	Aquashield CO2 System	United States Endoscopy Group, Inc.	FEQ	Class II	2012-03-28
K113702	Fotona Xp Nd: Yag Laser System	Fotona D.D.	PDZ	Class II	2012-03-28
K113695	Ellipse Precice Trauma Nail System	Ellipse Technologies, Inc.	HSB	Class II	2012-03-28
K113547	Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi Blood Glucose Monitoring System Gal	Apex Biotechnology Corp.	CGA	Class II	2012-03-28
K113324	Rexious Hook Fixation Systems	Dio Medical Co., Ltd.	KWP	Class II	2012-03-28
K113243	Em50 Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	LFR	Class II	2012-03-28
K112950	Jiangsu Healthy Way Mechanicl Wheelchair	Jiangsu Healthy Medical Equipment Co;Ltd	IOR	Class I	2012-03-28
K112948	Jiangsu Healthy Way Mechanical Wheelchair	Jiangsu Healthy Way Medical Equipment Co;Ltd	IOR	Class I	2012-03-28
K112834	Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles	Verichem Laboratories, Inc.	JIX	Class II	2012-03-28
K112774	Bd Recykleen Sharps Collectors	Becton Dickinson & Co	MMK	Class II	2012-03-28
K112422	Crag Lateral Flow Assay (Lfa)	IMMY, Inc.	GMD	Class II	2012-03-28
K112307	Resiglass Paste	Shofu Dental Corp.	EMA	Class II	2012-03-28
K110894	Contour Next Link Wireless Blood Glucose Meter	Medrad, Inc.	LFR	Class II	2012-03-28
K110690	One Personal Lubricant (Silicone)	One	NUC	Class II	2012-03-28
K110587	Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal, Low)	Medrad, Inc.	LFR	Class II	2012-03-28
K103035	Smartpilot View Model Mk04500	Draeger, Inc.	BSZ	Class II	2012-03-28
K120778	Brivo Mr355	GE Hangwei Medical Systems, Co. Ltd	LNH	Class II	2012-03-27
K120504	Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak	Bio-Rad Laboratories Inc.	DIF	Class I	2012-03-27
K120484	Visia Oncology	Mevis Medical Solutions AG	LLZ	Class II	2012-03-27
K120416	Insulation Tester	Spectrum Surgical Supply Corp.	GEI	Class II	2012-03-27
K120101	Independence Spacer	Globus Medical, Inc.	OVD	Class II	2012-03-27
K120096	Multifix P Knotless Fixation Device	ArthroCare Corporation	MBI	Class II	2012-03-27
K120061	Wound Protector	Covidien, Formerly US Surgical A Divison of Tyco H	GCJ	Class II	2012-03-27
K113815	Resscan	ResMed Corp	MNS	Class II	2012-03-27
K113672	Pch-2500 Digital Extraoral Source X-Ray System	Vatech Co., Ltd.	MUH	Class II	2012-03-27
K113369	Zimmer Persona Knee System	Zimmer GmbH	JWH	Class II	2012-03-27
K113247	Anesthesia Injection Tool Set	Ki Works Co., Ltd.	EJI	Class II	2012-03-27
K112977	Monarch III IOL Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)	Alcon Laboratories	MSS	Class I	2012-03-27
K112755	Abacus 5	Diatron US Inc	GKZ	Class II	2012-03-27
K111558	Surgicase Guide	Materialise N.V.	HAW	Class II	2012-03-27
K120572	Bioplex 2200 Torc Igg	Bio-Rad Laboratories Inc.	OMI	Class II	2012-03-26
K120270	Venus Spinal Fixation System	L&K Biomed Co.,Ltd.	NKB	Class II	2012-03-26
K110535	Alaris Pc Unit Module 8000 with Software Correction	CareFusion 303, Inc	FRN	Class II	2012-03-26
K120743	Speculum, Vaginal, Nonmetal	Welch Allyn Inc	HIB	Class II	2012-03-23