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 954 of 3531

510(k) clearances, page 954 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111065	Stryker (R) Patient Specific Polymer Implant	Howmedica Osteonics Corp. dba Stryker Orthopeadics	GWO	Class II	2011-07-14
K111034	Am USA 0.9% Sodium Chloride Flush Syringe	Am USA	NGT	Class II	2011-07-14
K110960	Royal Imperial Nitrile Examination Gloves Textured Powder-Free	Koon Seng Sdn Bhd	LZA	Class I	2011-07-14
K110869	Cara	Diagnos Inc	NFJ	Class II	2011-07-14
K110697	Tiger Syringes and Needles	Tiger Medical Products, Ltd.	FMF	Class II	2011-07-14
K110577	Osseofuse Dental Implant System	Dynamic Innovations, Inc.	DZE	Class II	2011-07-14
K110285	Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter	Nephros Inc	FIP	Class II	2011-07-14
K094048	Percupro Messenger Balloon Catheter	Cardiosolutions, Inc.	DYG	Class II	2011-07-14
K111850	Vaccess Pta Dilatation Catheter	C.R. Bard Inc	DQY	Class II	2011-07-13
K111652	Microlife Automatic Talking Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2011-07-13
K111312	Santeview	Sehyun Co., Ltd.	MQB	Class II	2011-07-13
K111231	Panoura 18S	The Yoshida Dental Mfg. Co., Ltd.	MUH	Class II	2011-07-13
K111062	Apex Knee System, Apex All Poly Tibia	Omni Life Science, Inc.	JWH	Class II	2011-07-13
K110842	Atlas Spine Pedicle Screw System	Atlas Spine, Inc.	NKB	Class II	2011-07-13
K110507	Cardiac Scanner and Processing System	Spectrum Dynamics (Israel), Ltd.	KPS	Class II	2011-07-13
K110418	Powder Free Nitrile Examination Gloves	W.A. Rubbermate Co., Ltd.	LZA	Class I	2011-07-13
K103077	ECG Pen	Meridian Dynamics Biomedical, Inc.	DPS	Class II	2011-07-13
K101089	Easyra Micro-Albumin Reagent and Calibrator	Medica Corp.	DCF	Class II	2011-07-13
K111747	Endologix Afx Introducer System	Endologix LLC	DYB	Class II	2011-07-12
K111397	Titan Ti Suture Anchor System	ArthroCare Corporation	MBI	Class II	2011-07-12
K111077	Orthosorb Resorbable Pins	Depuy Orthopaedics Inc.	OVZ	Class II	2011-07-12
K111076	Solanas Avalon Posterior Fixation System	Alphatec Spine, Inc.	NKB	Class II	2011-07-12
K111036	Easyra Hdl Reagent; Easyra Ldl Reagent; Easyra Chol Reagent; Easyra Trig Reagent	Medica Corp.	LBS	Class I	2011-07-12
K110884	Easyfit Silkgel Nasal Mask	Weinmann Gerate Fur Medizin GmbH + Co. KG	BZD	Class II	2011-07-12
K110670	Vlp Foot Talus Plates, Vlp Percutaneous Calcaneus Plates and Misc Vlp Bone Screws, Peri-Loc Ankle Fusion Plates	Smith & Nephew, Inc.	HRS	Class II	2011-07-12
K110538	Pro Fixation System	Synovis Orthopedic & Woundcare	HWC	Class II	2011-07-12
K101997	Ellipse Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2011-07-12
K094026	Steri-Dent, Steri-Sure	Cpac, Inc.	KMH	Class II	2011-07-12
K110824	Aragon Surgical RF System - 5Mm Laparoscopic Instrument	Aragon Surgical, Inc.	GEI	Class II	2011-07-11
K101194	Navigator Delivery System (or Navigator Ds) Model: Nav-010	Carticept Medical, Inc.	FRN	Class II	2011-07-11
K111851	Mediostar Next	Asclepion Laser Technologies GmbH	GEX	Class II	2011-07-08
K111601	Hero	Medical Predictive Science Corp.	DPS	Class II	2011-07-08
K111531	Rha2020	Annidis Health Systems Corp.	HLI	Class II	2011-07-08
K111506	Elecsys Precicontrol Varia 3	Roche Diagnostics GmbH	JJY	Class I	2011-07-08
K111435	Dp-50 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2011-07-08
K111150	Steritec Smart-Read Biological Test Pack with Instant Readout Integrator	Steritec Products Mfg. Co., Inc.	FRC	Class II	2011-07-08
K111031	Painfusor Catheter	Plan 1 Health SRL	BSO	Class II	2011-07-08
K110237	Hemosil Factor VIII Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2011-07-08
K111194	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	MNR	Class II	2011-07-07
K110696	Neuro Check Device with Io-Flex Wire	Baxano, Inc.	ETN	Class II	2011-07-07
K110044	Fora P30 Plus Multi-Mode Blood Pressure Monitoring System	Foracare, Inc.	DXN	Class II	2011-07-07
K103714	Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera	Ansell Healthcare Products LLC	KGO	Class I	2011-07-07
K102815	Surelift Prolapse System	Neomedic International	OTP	Class III	2011-07-07
K101381	Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt Systems	Integra LifeSciences Corporation	JXG	Class II	2011-07-07
K111619	Modified Concentric Microcatheter	Concentric Medical, Inc.	DQO	Class II	2011-07-06
K111571	Viper Systems	Johnson & Johnson	NKB	Class II	2011-07-06
K111569	Plateau Spacer System	Life Spine	MAX	Class II	2011-07-06
K111326	Osteowedge Opening Wedge Bone Locking System	Graham Medical Technologies, LLC	HRS	Class II	2011-07-06
K111012	Synthetic Vinyl Examination Gloves, Powder Free (Blue/green) (and Multiple Labels)	True Glove Factory	LYZ	Class I	2011-07-06
K110994	Parker 500	Arjohuntleigh AB	ILJ	Class II	2011-07-06