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 945 of 3531

510(k) clearances, page 945 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111765	Full Core Biopsy System	Promex Technologies, LLC	KNW	Class II	2011-09-06
K111734	Mysafety Syringe	Medicalchain Intl. Corp.	MEG	Class II	2011-09-06
K111650	Ids-Isys Ctx-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys...	Immunodiagnostic Systems Ltd.	JJX	Class I	2011-09-06
K111472	Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon	Tgm Medical, Inc.	LPH	Class II	2011-09-06
K111329	Nm-7000	Nuga Medical Co Ltd	JFB	Class II	2011-09-06
K112309	Digital Radiography	Canon Inc. -Medical Equipment Group	MQB	Class II	2011-09-02
K112237	Microsuture Anchors	Arthrex GmbH	HWC	Class II	2011-09-02
K111810	Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units	STERIS Corporation	MLR	Class II	2011-09-02
K111685	Ip Temp Cement	Shofu Dental Corp.	EMA	Class II	2011-09-02
K111682	Digital Radiography	Canon Inc. -Medical Equipment Group	MQB	Class II	2011-09-02
K111139	Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U	Ansell Healthcare Products LLC	KGO	Class I	2011-09-02
K110860	Comp a-I-R	Omron Healthcare Co., Ltd.	CAF	Class II	2011-09-02
K110791	Bigliani / Flatow (R) the Complete Shoulder Solution	Zimmer GmbH	KWT	Class II	2011-09-02
K110429	Prosim 4, Prosim 6, Prosim 8	Fluke Biomedical	DRT	Class II	2011-09-02
K102933	Gem-Tone Body Training System	Gemore Technology Co., Ltd.	NGX	Class II	2011-09-02
K101631	Fora Gd20 Blood Glucose Monitoring System, U-Rught Td-4252D Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-09-02
K112421	EMG Suction Unit	EMG Technology Co., Ltd.	JCX	Class II	2011-09-01
K112349	Versaport V2 Bladeless Optiical Trocar And/or Versaport Bladeless Optical Trocar	Covidien, Formerly US Surgical A Divison of Tyco H	GCJ	Class II	2011-09-01
K112311	Alp 501 Rb Pump System	Currie Medical Specialties, Inc.	JOW	Class II	2011-09-01
K112213	Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System	GE Healthcare	IYN	Class II	2011-09-01
K112199	Xtag Respiratory Viral Panel, Xtag Data Analysis Software (Tdas Rvp-1)	Luminex Molecular Diagnostics Inc	OCC	Class II	2011-09-01
K111143	Poly-Chem 90 Total Bilirubin	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	CIG	Class II	2011-09-01
K111059	Gyrus Acmil Bipolarlaproscopic Loop (Pks Bill)	Gyrus ACMI, Inc.	HIN	Class II	2011-09-01
K110944	Powder-Free Vinyl Patient Examination Gloves	Wangda Plastic Co., Ltd.	LYZ	Class I	2011-09-01
K110729	Aspire Hd Full-Field Digital Mammography System	FUJIFILM Healthcare Americas Corporation	MUE	Class II	2011-09-01
K110565	Abutments for Competitive Implant Systems-Nobel Replace	ZimVie US Corp LLC	NHA	Class II	2011-09-01
K110062	Mediplus-Foam Ag; Mediplus-Comfortfoam Ag; Mediplus-Superfoam Ag	Medipurpose Pte. Ltd.	FRO	Unclassified	2011-09-01
K103808	Sapphire Nc	Orbusneich Medical, Inc.	LOX	Class II	2011-09-01
K103358	Roma (He4 Eia + Architect Ca 125 II)	Fujirebio Diagnostics, Inc.	ONX	Class II	2011-09-01
K103331	Verify Biological Indicator Challenge Pack for Vaporized Vh202 Sterilization Processes	STERIS Corporation	JOJ	Class II	2011-09-01
K112376	S-Cath Esophageal Temperature Probe and Temperature Monitoring System	CIRCA Scientific, Inc.	FLL	Class II	2011-08-31
K112239	Steerable Guide Catheter	Abbott Vascular	DRA	Class II	2011-08-31
K111913	Capsure(r) Ps System	Spine Wave Inc	MNI	Class II	2011-08-31
K111742	Mdrive	Embla Systems	MNR	Class II	2011-08-31
K111314	Morpheus Ox	Widemed, Ltd.	MNR	Class II	2011-08-31
K111032	Cmc Cable Fix	Instratek, Inc.	HTN	Class II	2011-08-31
K103747	Elitech Clincal Systems Cholesterol Hdl Sl 2G, Hdl 2G Calibrator, Ldl Sl 2G, Ldl 2G Calibrator, Elitrol II & Elitech Sys	Elitechgroup Seppim S.A.S.	LBS	Class I	2011-08-31
K101635	Td-4239 Blood Glucose Monitoring System and Td-4239 Multi Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-08-31
K101204	Meg-2 Blood Glucose Monitoring System, Meg-2 50'S Test Strip, Meg-2 Control Solution	Apex Biotechnology Corp.	CGA	Class II	2011-08-31
K112163	Monica If24	Monica Healthcare	OSP	Class II	2011-08-30
K112029	Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol II Model Cali-05	ELITechGroup Inc	JIX	Class II	2011-08-30
K111942	Tsrh Spinal Systems	Medtronic Sofamor Danek USA Inc	NKB	Class II	2011-08-30
K111817	Palindrome Rt Chronic Catheter	Medtronic, Inc.	MSD	Class II	2011-08-30
K111548	Wireless/wired Fdr D-Evo Flat Pancel Detector System Model Dr-Id600 W/dr-Id611se	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2011-08-30
K111433	Depuy Sttune (Tm) Ps Knee System	Depuy Orthopaedics Inc.	OIY	Class II	2011-08-30
K111308	Zyto Hand Cradle	ZYTO Technologies, Inc.	GZO	Class II	2011-08-30
K111236	Introcan Safety (R) 3 Closed IV Catheter 18Ga X 1-3/4 (45Mm) and 18Ga X 1-1/4 (32Mm) / 20Ga X 1-1/4 (32Mm) / 20Ga X 1	B.Braun Melsungen AG	FOZ	Class II	2011-08-30
K110289	Friendship Medical Disposable Pre-Gelled Ag / Agcl Surface Electrode	Xian Friendship Medical Electronics Co., Ltd.	GXY	Class II	2011-08-30
K110129	Righton Zoom Slit Lamp Microscope with Photo Option	Rightmedical Products, LLC	HJO	Class II	2011-08-30
K101543	Tysonbio Blood Glucose Monitoring System, Models Ac100 and Ac200	Tyson Bioresearch, Inc.	NBW	Class II	2011-08-30