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 1453 of 3531

510(k) clearances, page 1453 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031737	Bact/alert Mp Culture Bottles (Plastic)	bioMerieux, Inc.	MDB	Class I	2003-07-14
K031724	Synthes Small Cobination Clamp-Mr Safe	Synthes (USA) Products LLC	KTT	Class II	2003-07-14
K031203	Biax A.f. Wrist/biax Advanced Fixation Wrist	Depuy Orthopaedics Inc.	JWJ	Class II	2003-07-14
K031183	Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate	Centerpulse Orthopedics, Inc.	JWH	Class II	2003-07-14
K031181	External Fixation Systems	Smith & Nephew, Inc.	KTT	Class II	2003-07-14
K031067	Femtex Junior/slender Regular Open-End Tampons	First Quality Hygienic, Inc.	HEB	Class II	2003-07-14
K031050	Pcw Percutaneous Compression Wire	Millennium Medical Technologies, Inc.	HWC	Class II	2003-07-14
K031032	Verdict II, Profile II	MEDTOX Diagnostics, Inc.	DJG	Class II	2003-07-14
K030769	Ultraflex Precision Colonic Stent	Boston Scientific Corporation	MQR	Class II	2003-07-14
K024007	Sunder Central Venous Catheter Kit, Models Sd-3L55f30j and Sd-3L70f30j	Sunder Biomedical Tech. Co., Ltd.	FOZ	Class II	2003-07-14
K023737	Injector	Anton Meyer & Co. AG	MSS	Class I	2003-07-14
K031914	Spinal Concepts, Inc. Cadence and Fortitude	Spinal Concepts, Inc.	MQP	Class II	2003-07-12
K030788	Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators	Geister Medizin Technik GmbH	DWP	Class II	2003-07-12
K032036	Gemini 16	Philips North America LLC	KPS	Class II	2003-07-11
K031823	Hedrocel Vertebral Body Replacement, Model 06-172-00Xx1	Implex Corp.	MQP	Class II	2003-07-11
K031808	Medrad Swabbable Valve Transfer Set	Medrad, Inc.	FPK	Class II	2003-07-11
K031720	Modification to Hermes o.r. Control Center	Computer Motion, Inc.	GCJ	Class II	2003-07-11
K031589	Bd Phoenix Automated Microbiology System-Nitrofurantoin Gram Positive	Becton Dickinson & Co	LON	Class II	2003-07-11
K031417	Ilt Safe Cross 0.035 Support Catheter, Model C135sn1	Intra Luminal Therapeutics, Inc.	DQY	Class II	2003-07-11
K031366	Premier 9000 8 Channel Phased Array Ctl Spine Coil	GE Healthcare Coils	MOS	Class II	2003-07-11
K031339	Optibolus	Mallinckrodt Inc., Liebel-Flarsheim Business	DXT	Class II	2003-07-11
K031212	Temporary Resin Cement	Parkell, Inc.	EMA	Class II	2003-07-11
K031060	Nano Tech and Super Nano Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	2003-07-11
K030992	C. Diff Chek - 60	Techlab, Inc.	LLH	Class I	2003-07-11
K030991	C. Diff Chek - 30	Techlab, Inc.	LLH	Class I	2003-07-11
K030841	Cook Gastric Sizing Balloon Catheter	Cook Inc.	KNT	Class II	2003-07-11
K030754	A/c Enzymatic Homocysteine Assay	Anticancer, Inc.	LPS	Class II	2003-07-11
K030703	Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips	Home Diagnostics, Inc.	NBW	Class II	2003-07-11
K030600	Aution Jet Aj-4270 Urine Analyzer	International Remote Imaging Systems	KQO	Class I	2003-07-11
K030547	Modification to Zap Guard Defibrillator Test Probe	Guardian Angel Products, Inc.	DRL	Class II	2003-07-11
K030456	Vasc-Alert	Vasc-Alert, LLC	KOC	Class II	2003-07-11
K024343	Butler Gum Prophy Paste with Novamin	Usbiomaterials Corp.	EJR	Class I	2003-07-11
K032044	X-Prot Duo Port	C.R. Bard Inc	LJT	Class II	2003-07-10
K031716	Special+, S-Needle J-Type, S-Needle B-Type	Asia-Med GmbH and CO KG	MQX	Class II	2003-07-10
K031530	Bd Phoenix Automated Microbiology System-Nitrofurantoin-8-512 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-07-10
K031482	Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1Mm Cryoprobe, C) Cryostar 2Mm Cryoprobe, D) Convenience	Cryomedical Instruemts, Ltd.	GXH	Class II	2003-07-10
K031410	Vitek 2 Gram Positive Linezolid for Streptococcus Pneumoniae	bioMerieux, Inc.	LON	Class II	2003-07-10
K031342	Jason Marine All Terrain Electric Wheelchair, Model Seeker II	Jason Marine Enterprises, Inc.	ITI	Class II	2003-07-10
K031174	Body Signal ECG Electrode	Wandy Rubber Industrial Co., Ltd	DRX	Class II	2003-07-10
K031115	Rh-900	Iomed, Inc.	KTB	Class II	2003-07-10
K031093	Ebi Xfix Optirom Knee Fixator	Ebi, LLC	KTT	Class II	2003-07-10
K031059	IVD Cryptosporidium Antigen Detection Assay, Model Cp-96	IVD Research, LLC.	MHJ	Class II	2003-07-10
K031045	Aerolet Toilet Lift, Model Aer-01	Economic Holland B.V.	INO	Class II	2003-07-10
K031036	Gebauer's Skin Refrigerant (Mist Spray), Model P/n 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/n-03	Gebauer Co	MLY	Unclassified	2003-07-10
K030852	4 French & 5 French Electrophysiology Diagnostic Catheters Models 5Uexxx, 5Bexxx and 5Fexxx, and 4Uexxx, 4Bexxx and 4Fex	Mogul Enterprises	DRF	Class II	2003-07-10
K030760	Coach 888W	Wheelchair & Scooter Express	ITI	Class II	2003-07-10
K032040	Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator	Dideco S.p.A.	KFM	Class II	2003-07-09
K031913	Vinyl Examination Gloves, Powder Free, Violet Color	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	2003-07-09
K031868	Prophypearls	Kavo America	EFB	Class I	2003-07-09
K031824	Cobas Integra Cholesterol Gen. 2	Roche Diagnostics GmbH	CHH	Class I	2003-07-09