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 1026 of 3531

510(k) clearances, page 1026 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100273	Instaflo Bowel Catheter System Kit	Hollister, Inc.	KNT	Class II	2010-04-22
K100113	Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for Ge 3T MRI System, Model 4000451-51	Sentinelle Medical, Inc.	MOS	Class II	2010-04-22
K100096	Linac Collimator Assembly Housing (Lcah) Model Lcahart	Integra Radionics, Inc.	IYE	Class II	2010-04-22
K094045	Modificaiton to: Cardo Medical Hip System	Cardo Medical Corp.	LPH	Class II	2010-04-22
K094038	Compact Touch	Quantel S.A.	IYO	Class II	2010-04-22
K093977	Alligator-Hd Retrieval Device (Ard-Hd), Model Fa-88840-Xx	Chestnut Medical Technologies, Inc.	DQY	Class II	2010-04-22
K093974	Esenor Fii-Fv-Mthfr Genotyping Test, Esenor Fii-Fv Genotyping Test, Esenor Fii Genotyping	Osmetech Molecular Diagnostics	NPQ	Class II	2010-04-22
K093971	Dental Handpiece	North West Medical Instrument (Group) Co., Ltd.	EFB	Class I	2010-04-22
K093889	Modification to: Hg III Ultra Wide System	Hiossen, Inc.	DZE	Class II	2010-04-22
K093871	Periophil B-Tcp	Cytophil, Inc	LYC	Class II	2010-04-22
K093799	Tornier Surgical Mesh	TORNIER Inc.	FTL	Class II	2010-04-22
K093343	Grafty Quickset	Graftys	MQV	Class II	2010-04-22
K091404	Ivue, Model 100	Optovue Inc.	OBO	Class II	2010-04-22
K100789	Modificaton to: Steerable Guide Catheter, Model Sgc01st	Evalve, Inc.	DRA	Class II	2010-04-21
K100470	Gtx 12 Gidewire	Medtronic, Inc.	DQX	Class II	2010-04-21
K100415	Acupulse 30/40 St CO2 Laser System and Acupulse 40Wg CO2 Laser System	Lumenis Ltd	GEX	Class II	2010-04-21
K100229	Ventrio Hernia Patch	C.R. Bard Inc	FTL	Class II	2010-04-21
K100195	Nds Surgical Imaging, Llc for the Zerowire Duo Wireless Hd Video Transfer System, Model Wu-Wx-Wy (Where U=r or T, W=p, X	NDS Surgical Imaging, LLC	GCJ	Class II	2010-04-21
K092240	Acupuncture Needles	Haenglim Seowon Medical Co.	MQX	Class II	2010-04-21
K090982	Smith & Nephew Hip Systems with Ha	Smith & Nephew, Inc.	MEH	Class II	2010-04-21
K100618	Maxlock Extreme Extremity Plating System with Variable Angle Technology	TORNIER Inc.	HRS	Class II	2010-04-20
K100383	Vitaphone. Model 100 Bt	Vitasystems GmbH	DXH	Class II	2010-04-20
K100312	Distalock Femoral Intramedullary Nail System	Dgimed Ortho, Inc.	HSB	Class II	2010-04-20
K100208	Imc Surgical Drape	Intl. Medsurg Connection, Inc.	KKX	Class II	2010-04-20
K100155	Truvue Wireless Ambulatory ECG Monitoring System	Biomedical Systems Corp.	DSI	Class II	2010-04-20
K093431	Clearway Otw Model 85912	Atrium Medical Corporation	DQY	Class II	2010-04-20
K100159	Smith and Nephew Twinfix Ultra Ti Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2010-04-19
K092048	One Step Eddp (Methadone Metabolite) Test Strip	Biosite Incorporated	DJR	Class II	2010-04-19
K100663	Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321	Boston Scientific Corporation	NAJ	Class II	2010-04-16
K100241	Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680	B.Braun Medical, Inc.	BSP	Class II	2010-04-16
K100173	Iyunni 3Id Tri-Funnel Feeding Tube Kit	Sainath Intellectual Properties, LLC	KNT	Class II	2010-04-16
K100135	Gds-Dc12	Guided Delivery Systems	DQY	Class II	2010-04-16
K100127	Eli 230 Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2010-04-16
K094018	Lc Bead Microspheres, Bead Block Compressible Microspheres	BIOCOMPATIBLES U.K. Limited, a BTG Company	HCG	Class II	2010-04-16
K093880	Peanut Growth Control Plating System	Ebi, LLC	HRS	Class II	2010-04-16
K093780	Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment	Astra Tech, Inc.	NHA	Class II	2010-04-16
K093511	Soring Mbc200/bcc140	Soring GmbH Medizintechnik	GEI	Class II	2010-04-16
K093186	Ambu Ascope and Monitor	Ambu A/S	BTR	Class II	2010-04-16
K093014	American Dental Products Se Bondeasy	American Dental Products, Inc.	KLE	Class II	2010-04-16
K092031	Vapor-Clear, Model 100	Axon Medical	CBN	Class II	2010-04-16
K090436	Airwayease Mas	Orthoplant Dental Lab	LRK	Class II	2010-04-16
K100745	Lifebed Network Patient Vigilance System	Hoana Medical, Inc.	DRT	Class II	2010-04-15
K100394	Multi-Parameter Patient Monitor, Model# Pms8210a	Shanghai 3f Electronics Co, Ltd.	MWI	Class II	2010-04-15
K100191	Lanx Posterior Cervicothoracic Spinal Fixation System (Pcfs)	Lanx, Inc.	KWP	Class II	2010-04-15
K100116	Lasertouchone (OTC)	Laser Health Technologies	NUH	Class II	2010-04-15
K100005	Bd Pen Needle	Becton Dickinson & Co	FMI	Class II	2010-04-15
K093991	Slr-Plus Standard and Lateral Femoral Stems	Smith & Nephew, Inc.	LZO	Class II	2010-04-15
K093922	Inomax Ds	Mallinckrodt Manufacturing LLC	MRN	Class II	2010-04-15
K093836	Elecsys Tsh Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-04-15
K093611	Vitros Chemistry Products CO2 Dt Slides; Vitros Chemmistry Products Dt Calibrator Kit, Models CO2 Dt Slides, 172 0002;	Ortho-Clinical Diagnostics, Inc.	KHS	Class II	2010-04-15