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 2026-11-05, 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 1242 of 3531

510(k) clearances, page 1242 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061972	Connect Imaging Pacs	Connect Imaging, Inc.	LLZ	Class II	2006-09-18
K061860	Clearfil Majesty Esthetic	Kuraray Medical, Inc.	EBF	Class II	2006-09-18
K061658	Spirit, Model M, U; Docportmacro, Model M, U, L	Dentall, Inc.	EBZ	Class II	2006-09-18
K061532	Gentle Colon (Revision 2.0)	Rendoscopy, Inc.	LLZ	Class II	2006-09-18
K060953	Occultech Fecal Occult Blood Rapid Test	YD Diagnostics	KHE	Class II	2006-09-18
K060644	Ahmed Glaucoma Valve, Model M4	New World Medical, Inc.	KYF	Class II	2006-09-18
K062608	29G and 30G K-Pack II Needle	Terumo Europe N.V.	FMI	Class II	2006-09-15
K062458	Ethmoid Sinus Spacer	Acclarent Inc	KAM	Class I	2006-09-15
K062425	Lifecath S Picc and Midline Catheter	Vygon Corp.	LJS	Class II	2006-09-15
K062417	Xplorer 1100	Imaging Dynamics Company, Ltd.	KPR	Class II	2006-09-15
K062406	Aesculap Neuro Patties	Aesculap Inc	HBA	Class II	2006-09-15
K062216	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	HRS	Class II	2006-09-15
K062092	Prevu Point of Care Skin Sterol Test	Premd, Inc.	LBS	Class I	2006-09-15
K061974	Gem Premier 4000 with Iqm, Model 4000; Gem Cvp 1 and 2 with Co-Ox; Gem Cvp 3 and 4 Hematocrit	Instrumentation Laboratory Co.	CHL	Class II	2006-09-15
K061877	Wallflex Enteral Colonic Stent with Anchor Lock Delivery System	Boston Scientific Corporation	MQR	Class II	2006-09-15
K061864	Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560	Dukal Corp.	FXX	Class II	2006-09-15
K061780	Telephone Electrocardiograph Transmitter and Receiver, Ttm for Windows +	Rozinn Electronics, Inc.	DXH	Class II	2006-09-15
K061744	Cochlea-Scan / Cochlea-Scan Plus	Bio-Logic Systems Corp.	EWO	Class II	2006-09-15
K061741	Mac-Lab/cardiolab /Combolab/specialslab System	GE Healthcare	DQK	Class II	2006-09-15
K061690	Surgical Headlight	Gulf Fiberoptics, Inc.	FST	Class II	2006-09-15
K061685	Pulsera	Philips North America LLC	IZL	Class II	2006-09-15
K061662	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Luxiong Plastic Products Co., Ltd.	LYZ	Class I	2006-09-15
K061659	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Luxiong Plastic Products Co., Ltd.	LYZ	Class I	2006-09-15
K061557	Fusion	Medwave, Inc.	DXN	Class II	2006-09-15
K061502	Medic4all Telemedicine System Vms-01	Medic4all (Israel), Ltd.	DRG	Class II	2006-09-15
K061190	Access Intact Pth and Calibrators, Models a 16972 and a 16953	Siemens Healthcare Diagnostics Inc.	CEW	Class II	2006-09-15
K060944	Nutrisafe 2	Vygon Corp.	FPD	Class II	2006-09-15
K060770	Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls	Ortho-Clinical Diagnostics, Inc.	LOL	Class II	2006-09-15
K060681	Medtronic Ps Medical Strata Type Value	Medtronic Neurosurgery	JXG	Class II	2006-09-15
K062424	Confidence Ex High Viscosity Bone Cement	Disc-O-Tech Medical Technologies, Ltd.	NDN	Class II	2006-09-14
K062391	Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00	Triage Medical, Inc.	MRW	Unclassified	2006-09-14
K062335	Sedecal X Plus Lp Plus	Sedecal S.A.	KPR	Class II	2006-09-14
K062182	Dimension Vista System Ecstasy Calibrator, Model Kc520	Siemens Healthcare Diagnostics Inc.	DLJ	Class II	2006-09-14
K062162	Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - Kc510)	Siemens Healthcare Diagnostics Inc.	DKB	Class II	2006-09-14
K062087	Bd Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962	Becton, Dickinson and Company, BD Biosciences	GKZ	Class II	2006-09-14
K061932	Bernoulli Management System (Ms) Software	Cardiopulmonary Corp.	MSX	Class II	2006-09-14
K061824	Tornier Cement Restrictor	TORNIER Inc.	LZN	Class II	2006-09-14
K061695	LED Prolux 770	Peng Lim Enterprise Co., Ltd.	EBZ	Class II	2006-09-14
K061577	Ovaltwist Pedicle Screw System	Signus Medizintechnik GmbH	MNH	Class II	2006-09-14
K061225	Stryker Disposable Laparoscopic Scissors	Stryker Corp.	GEI	Class II	2006-09-14
K060762	Aesculap Peek Vertebral Body Replacement System	Aesculap Inc	MQP	Class II	2006-09-14
K060678	Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,calibrator,controls	Ortho-Clinical Diagnostics, Inc.	LOL	Class II	2006-09-14
K052475	Vygon Nutriline and Nutriline Twinflow Catheters	Phoenix Biomedical Corp.	LJS	Class II	2006-09-14
K062468	Spectrum M2 Monitor	Spectrum Medical Inc	DRY	Class II	2006-09-13
K062405	Xplorer 1590	Imaging Dynamics Company, Ltd.	KPR	Class II	2006-09-13
K062319	Calibrator for Automated Systems (C.f.a.s.), Model 10759350 360	Roche Diagnostics GmbH	JIX	Class II	2006-09-13
K062207	Bd Phoenix Automated Microbiology System - Cefuroxime (Gn) 1-64 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-09-13
K062141	Mammopad Radiolucent Cushion	Biolucent, Inc.	IYX	Class I	2006-09-13
K061809	Artegral Imcrown	Merz Dental GmbH	EBG	Class II	2006-09-13
K061092	Baxter Duplospray Mis Applicator	Micromedics, Inc.	FMF	Class II	2006-09-13