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 1025 of 3531

510(k) clearances, page 1025 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100410	Piezoelectric System	Satelec	JDX	Class II	2010-04-28
K100378	1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4	The Daavlin Distributing Co.	FTC	Class II	2010-04-28
K100319	Merit Manifold with Integrated Transducer, Model 203Ltchn-R; 503Ltchn-R; 203Ltphn-R,203ltchwn-R; 503Ltchwn-R; 203L	Merit Medical Systems, Inc.	DTL	Class II	2010-04-28
K100258	Electrosurgical Pencil with Electrode, Wp200	Wickimed Supply Company Limited.	GEI	Class II	2010-04-28
K093770	Extremity Medical Screw System	Extremity Medical, LLC	HWC	Class II	2010-04-28
K093561	Zimmer Trabecular Metal Modular Acetabular System	Zimmer GmbH	LPH	Class II	2010-04-28
K093129	Illumina Verncode Genotyping Test for Facor V and Factor II	Illumina, Inc.	NPQ	Class II	2010-04-28
K093128	Illumina Beadxpress System	Illumina, Inc.	NSU	Class II	2010-04-28
K092901	Epicage Interbody Fusion Device	R Tree Innovations	MAX	Class II	2010-04-28
K092611	Sonarmed Airway Monitoring System, Model 0901	Sonarmed, Inc.	OQU	Class II	2010-04-28
K094040	F&p Icon Series CPAP	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2010-04-27
K094031	Elecsys Folate III Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-04-27
K093377	Polaris Contact Lens Case	Reliance Design & Manufacturing Corp.	LRX	Class II	2010-04-27
K093241	V7 Portable Suction Units	Hersill, S.L.	BTA	Class II	2010-04-27
K091472	Uritest 50 and Uritest 500 Urine Analyzer	Arj Medical, Inc.	KQO	Class I	2010-04-27
K100810	Elecsys C-Peptide Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-04-26
K100548	Versaport Bladeless Low Profile Trocar Model Nb3shflp, Nb5shflp, Nb5stflp	Covidien Lp, Formerly Registered AS Tyco Healthcar	GCJ	Class II	2010-04-26
K100268	Sechrist Monoplace Hyperbaric Oxygen Chamber	Sechrist Industries Inc	CBF	Class II	2010-04-26
K094025	Crescent Spinal System	Medtronic Sofamor Danek	MAX	Class II	2010-04-26
K093478	Kodak Rvg 6500 System and Kodak Rvg 6500 Ips System	Trophy	MUH	Class II	2010-04-26
K093207	Enduramesh, Model 762.Xxx	Lucero Medical, LLC	MQP	Class II	2010-04-26
K092911	Smart Hba1c Assay Kit, Model Dz168b-Poc, Smart Hba1c Assay Control Kit, Model Dz168b-Con, Smart Hbac1c Analyzer	Diazyme Laboratories, Inc.	JJX	Class I	2010-04-26
K092748	Sureshot Tan Nails and Accessories	Smith & Nephew, Inc.	HSB	Class II	2010-04-26
K092382	Nexus Pressure Rated Extension Sets	Nexus Medical, LLC	FPA	Class II	2010-04-26
K092171	Volux, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	MUH	Class II	2010-04-26
K100941	Infinity Mcable - Mainstream CO2	Draeger Medical AG & Co. KG	CCK	Class II	2010-04-23
K100838	Ergo Imaging System	Digirad Corp.	IYX	Class I	2010-04-23
K100528	Breathe Technologies Ventilator and Accessories Bt-V2s	Breathe Technologies, Inc.	ONZ	Class II	2010-04-23
K100449	Minxray Model Cmdr-2S	Minxray Inc	IZL	Class II	2010-04-23
K100343	Pap-Cap	Pur-Sleep, Inc.	BZD	Class II	2010-04-23
K100315	12 Lead Glove	I Needmd, Inc.	DRX	Class II	2010-04-23
K100283	Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes C-Vt, C-Vtic	Cook Inc.	BTO	Class II	2010-04-23
K100237	Dialysate Meter, Model D-6	Myron L Company	FLB	Class II	2010-04-23
K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	OOE	Class II	2010-04-23
K093940	Advocate Redi-Code Dash Blood Glucose Monitoring System Model Td-4276	Taidoc Technology Corporation	NBW	Class II	2010-04-23
K093705	Fuorecam	Therapeutic Technologies, Inc.	NBL	Class II	2010-04-23
K093618	Bili-Mirror Model Blm-1	Physician Engineered Products, Inc.	LBI	Class II	2010-04-23
K093421	Elecsys Testosterone II Immunoassay	Roche Diagnostics GmbH	CDZ	Class I	2010-04-23
K092542	M	Mediscitec, Inc.	DZE	Class II	2010-04-23
K091987	Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip	LeMaitre Vascular Inc.	FZP	Class II	2010-04-23
K090882	Flush Syringe Filled with 0.9% Sodium Chloride	Abbott Medical	NGT	Class II	2010-04-23
K100959	Specimen Retrieval System	Applied Medical Resources Corp	GCJ	Class II	2010-04-22
K100855	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Suzhou Shengyuda Plastic Products Co., Ltd.	LYZ	Class I	2010-04-22
K100803	Olympus Flushing Pump Ofp Model: Ofp-1	Keymed, Inc.	FEQ	Class II	2010-04-22
K100526	Ameritus Entral (Tm) Enteral Feeding Tube	Kentec Medical, LLC	FPD	Class II	2010-04-22
K100454	Hydrocoil Embolic System-Hydroframe Model 100931Hfm-V, 101243Hfm-V, 180827Hfm-V, 181139Hfm-V, 181445Hfm-V, 181850Hfm-V	Terumo Cardiovascular Systems Corporation	HCG	Class II	2010-04-22
K100400	Prestodr Portable	CMT Medical Technologies, Ltd.	IZL	Class II	2010-04-22
K100377	Diamondback Spinal System	Eminent Spine	MNI	Class II	2010-04-22
K100361	Nanoss Bone Void Filler	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2010-04-22
K100334	Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811	B. Braun Avitum AG	KDI	Class II	2010-04-22