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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 852 of 3530

510(k) clearances, page 852 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123613	Synspar Advanced	Ardent, Inc.	EIH	Class II	2013-02-20
K123425	Twinfix Ti 3.5Mm Suture Anchor with Two Ultrabraid Suture #2 with Needles, Sl	Smith & Nephew, Inc.	MBI	Class II	2013-02-20
K123424	Mdu5 Plus Sterile Bag	Boston Scientific Corporation	ITX	Class II	2013-02-20
K123595	Nexus Rmgi	Sybron Dental Specialties, Inc.	EMA	Class II	2013-02-19
K123588	Intradermal Adapter	West Pharmaceutical Services, Inc.	FMF	Class II	2013-02-19
K123575	Mammoworkstation	Image Diagnost International GmbH	LLZ	Class II	2013-02-19
K123469	Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile	Wear Safe (Malaysia) Sdn. Bhd.-Facility II	LZA	Class I	2013-02-19
K123154	Artas System from Restoration Robotics	Venus Concept Inc.	ONA	Class II	2013-02-19
K122477	Lifestyles Luxe Premium Personal Lubricant	Ansell Healthcare Products LLC	NUC	Class II	2013-02-19
K121928	Desara Sl	Caldera Medical, Inc.	OTN	Class II	2013-02-19
K120851	Communify Pacs Viewer	Communify Health, LLC	LLZ	Class II	2013-02-19
K110941	Revolix Jr 30, Revolix Jr 50, Revolix Jr 160, Revolix Fr 200	Allmed Systems, Inc.	GEX	Class II	2013-02-19
K130200	Piccolo Total Cholesterol - Capillary Test System	Abaxis Inc	CHH	Class I	2013-02-15
K123835	2008 Hemodialysis Sorbent System	Renal Solutions, Inc.	FKT	Class II	2013-02-15
K123525	Gridlock Plating System	Trilliant Surgical LLC	HRS	Class II	2013-02-15
K123321	Dimension Chemistry III Calibratory	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2013-02-15
K123320	Dimension Ammonia Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	JIF	Class I	2013-02-15
K123164	Spinefrontier Pedfuse Pedicle Screw System	SPINEFRONTIER, Inc. dba LESspine Innovations	MNH	Class II	2013-02-15
K122894	Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic	Geistlich Pharma AG	NPM	Class II	2013-02-15
K122726	Cpi Rad Vision	Communications & Power Industries Canada, Inc.	KPR	Class II	2013-02-15
K122710	Transcranial Doppler with Robotic Probe Headband	Shenzhen Delicate Electronics Co., Ltd.	IYN	Class II	2013-02-15
K122518	Synster (Cervical,alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa Cage	BM Korea Co., Ltd.	ODP	Class II	2013-02-15
K122315	Freshkon 1-Day Alluring Eyes (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Freshkon 1-Day Mosaic (Etafilc	Oculus Private Limited	LPL	Class II	2013-02-15
K122177	Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/dl, Elitech Clinical Systems Urine Control Bi-Level	ELITechGroup Inc	JIT	Class II	2013-02-15
K121608	Vitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total Calibrators	Ortho-Clinical Diagnostics, Inc.	MRG	Class II	2013-02-15
K130055	Acon Bup One Step Buprenorphine Test Strip	Guangzhou Wondfo Biotech Co., Ltd.	DJG	Class II	2013-02-14
K130049	Monoject 12Ml Syringe	Nipro Medical Corporation	FMF	Class II	2013-02-14
K123918	Motionloc Screw for Ncb Polyaxial Locking Plate System	Zimmer GmbH	HRS	Class II	2013-02-14
K123851	Glucose Meter-Check Solution for Roche Accu-Chek	Bionostics, Inc.	JJX	Class I	2013-02-14
K123840	Connect for Da Vinci Surgical System(s)	Intuitive Surgical, Inc.	NAY	Class II	2013-02-14
K123826	Vitro Molar	DFL Industria e Comercio SA	EMA	Class II	2013-02-14
K123647	Circuflow 5208 Sequential Compression Device	Devon Medical, Inc.	JOW	Class II	2013-02-14
K123623	Illico Mis Posterior Fixation System	Alphatec Spine, Inc.	NKB	Class II	2013-02-14
K123240	Speedlock Hip Knotless Fixation Implant	ArthroCare Corporation	MBI	Class II	2013-02-14
K123235	Equaflow Multivalve Infusion Catheter	Cook Incorporated	DYB	Class II	2013-02-14
K123211	A5 Anesthesia Delivery System	Datascope Corp., Patient Monitoring Division	BSZ	Class II	2013-02-14
K123176	ISO-Gard Clearair Mask	Teleflexmedical, Inc.	CBN	Class II	2013-02-14
K123166	Triathlon All-Polyethylene Condylar Stabilizing (Cs) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P	Howmedica Osteonics Corp	JWH	Class II	2013-02-14
K123072	Vashe Wound Therapy Solution	Puricore, Inc.	FRO	Unclassified	2013-02-14
K122184	ECG Check	Cardiac Designs, LLC	DXH	Class II	2013-02-14
K122054	Lifestyles Natural Personal Lubricant	Ansell Healthcare Products LLC	NUC	Class II	2013-02-14
K121919	Surgical Drape with AAMI Liquid Barrier Level IV	Exact Medical Manufacturing, Inc.	KKX	Class II	2013-02-14
K121433	Goodlife Cs-200 (Single Patient Use), Cs-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems	HMD Biomedical, Inc.	LFR	Class II	2013-02-14
K121241	Male Latex Condom	Nulatex Sdn. Bhd.	HIS	Class II	2013-02-14
K120675	Digital Automatic Blood Pressure Monitor Bpm11 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2013-02-14
K120673	Digital Automatic Wrist Blood Pressure Monitor Wbpm15 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2013-02-14
K120181	Lufucon Silver Alginate Dressing 50X50mm, Lufucon Silver Alginate Dressing 100X100mm, Lufucon Silver Dressing 200X100mm	HuiZhou Foryou Medical Devices Co., Ltd.	FRO	Unclassified	2013-02-14
K120038	A200 Knee System	Renovis Surgical Technologies, LLC	OIY	Class II	2013-02-14
K123524	Medtronic Strata Nsc Lumboperitoneal Valve and Shunt System	Medtronic Neurosurgery	JXG	Class II	2013-02-13
K123412	Range Spinal System, Small Strature Components	K2M, Inc	OSH	Class II	2013-02-13