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 917 of 3530

510(k) clearances, page 917 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111726	Pathway Avid	Custom Spine, Inc.	MAX	Class II	2012-02-06
K111481	Corin Trinity Acetabular System Ecima Liners	Corin USA	OQI	Class II	2012-02-06
K120129	Mantaray Catheter	Boston Scientific Corporation	DQY	Class II	2012-02-03
K120103	Rest Assured Generation III Dental Protector	Ranir, LLC	OBR	Unclassified	2012-02-03
K120068	Conformis Itotal Cr Knee Replacement System (Krs)	ConforMIS, Inc.	JWH	Class II	2012-02-03
K120047	Coral Spinal System	Theken Companies LLC	NKB	Class II	2012-02-03
K113359	Chison Diagnostic Ultrasound System,convex Probe,linear Probe,transvaginal Micro-Convex Probe	Chison Medical Imaging Co., Ltd.	IYN	Class II	2012-02-03
K113334	Avex Cx2 and Avex Cxi2 Ceramic Brackets	Opal Orthodontics by Ultradent Products	NJM	Class II	2012-02-03
K113322	Conserve Thin Shell	Wrightmedicaltechnologyinc	KWA	Class III	2012-02-03
K112953	Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics	Teratech Corp.	IYN	Class II	2012-02-03
K112540	S-Mini Implant System	Neobiotech Co., Ltd.	DZE	Class II	2012-02-03
K112188	Piezotome Solo	Satelec - Acteon, Inc.	DZI	Class II	2012-02-03
K112099	Contour Healer	Contour Healer, LLC	NHA	Class II	2012-02-03
K111684	Playtex Sport (Unscented) ,(Scented) with Odorshield	Playtex Manufacturing Inc.	HIL	Class II	2012-02-03
K110550	Bright Embrace Model Sbl60	Physician Engineered Products, Inc.	LBI	Class II	2012-02-03
K103325	Ids-Isys Intact Pth	Immunodiagnostic Systems Ltd.	CEW	Class II	2012-02-03
K120017	Fresenius 2008 Hemodiaysis Machine with Bibag System	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2012-02-02
K120006	Hero Graft	Hemosphere, Inc.	DSY	Class II	2012-02-02
K113197	Apc Flash-Free Adhesive	3M UNITEK Corporation	DYH	Class II	2012-02-02
K113165	Mini-Medic	Athena GTX	MWI	Class II	2012-02-02
K113074	Cmap Pro	Medical Technologies, Inc.	IKN	Class II	2012-02-02
K112976	Nitrile Powder Free Examination Gloves (White) with Colloidal Oatm	Hartalega Snd. Bhd.	LZA	Class I	2012-02-02
K110051	Radialsource Transradial Access Introducer Kit	Great Batch Medical	DYB	Class II	2012-02-02
K113755	Savannah Technologies Spinal System	Savannah Technologies, LLC	MNI	Class II	2012-02-01
K113744	Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)	Angiotech	NEW	Class II	2012-02-01
K113623	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2012-02-01
K113308	Bruno Elan Stairway Elevator	Bruno Independent Living Aids, Inc.	ILK	Class II	2012-02-01
K113149	Synthes Uss Connectors	Synthes GmbH	MNI	Class II	2012-02-01
K113053	BIPAP a 30 Ventilatory Support System	Respironics, Inc.	MNS	Class II	2012-02-01
K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	JWH	Class II	2012-02-01
K112736	Pass Lp Spinal	Medicrea International	JDQ	Class II	2012-02-01
K112650	Connexall Suite of Software Products	Connexall USA, Inc.	MSX	Class II	2012-02-01
K112074	Everyway Traction Unit, Model Ever-Trac Et-800	Everyway Medical Instruments Co., Ltd.	ITH	Class II	2012-02-01
K111515	Spsmedical Sporview Steam Bi	Spsmedical Supply Corp.	FRC	Class II	2012-02-01
K111411	Freemie (R)	Dao Health	HGX	Class II	2012-02-01
K111364	Haptite Coating Implant System	Dentis Co.,Ltd	DZE	Class II	2012-02-01
K110899	Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit	Gold Standard Diagnostics, LLC	LYR	Class I	2012-02-01
K110691	One Personal Lubricant (Water Based)	One	NUC	Class II	2012-02-01
K103295	Quickscreen Cocaine 150 Screening Test	Phamatech Inc.	DIO	Class II	2012-02-01
K120058	Transtek Blood Pressure Monitor	Zhongshan Transtek Electronics Co., Ltd	DXN	Class II	2012-01-31
K113525	Activecare Dvt Activecare+sft	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2012-01-31
K113014	Claw II Polyaxial Compression System and Ortholoc 3Dsi Locking Screws	Wrightmedicaltechnologyinc	HRS	Class II	2012-01-31
K112526	Twinfix Ultra Ti, Twinfix Ultra Pk, Twinfix Ultra Ha Suture Anchors	Smith & Nephew, Inc.	MBI	Class II	2012-01-31
K112143	Audit Microcv T-Uptake Linearity	Aalto Scientific Ltd.	JJX	Class I	2012-01-31
K111305	Universal Digital Interface Wireless - UDI 1417W	Meridian Medical Systems, LLC	MQB	Class II	2012-01-31
K113764	Glucose Meter-Check Solution for Infopia	Bionostics, Inc.	JJX	Class I	2012-01-30
K113555	Am USA 0.9% Sodium Chloride Flush Syringe	Am USA	NGT	Class II	2012-01-30
K113076	Caas a-Valve	PIE Medical Imaging B.V.	LLZ	Class II	2012-01-30
K113048	Maxlock Extreme System	TORNIER Inc.	HRS	Class II	2012-01-30
K113015	Aldahol V High Level Disinfectant	Microchem Laboratories, Inc.	MED	Class II	2012-01-30