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 836 of 3530

510(k) clearances, page 836 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123133	Barle Tissue Adhesive	Advanced Medical Solutions (Plymouth), Ltd.	MPN	Class II	2013-05-22
K122625	Getinge 800Hc- Series Steam Sterilizer	Getinge Sourcing, LLC	FLE	Class II	2013-05-22
K131119	Solanas Posterior Stabilization System	Alphatec Spine, Inc.	NKB	Class II	2013-05-21
K131093	Ortholoc(r) 3Di Ankle Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2013-05-21
K130842	Allura Xper Fd or Table Series; Allura Xper Fd10 Series; Allura Xper Fd20 Series; Allura Xper Fd Biplane Series	Philips Medical Systems Nederland B.V.	IZI	Class II	2013-05-21
K130539	Healix Advance Knotless Peek Anchor (4.75Mm)(5.5mm)	DePuy Mitek, Inc.	MBI	Class II	2013-05-21
K130189	Xtag Cyp2d6 Kit V3 (Including Tdas Cyp2d6 Software)	Luminex Molecular Diagnostics Inc	NTI	Class II	2013-05-21
K130077	Remstar Se	Respironics, Inc.	BZD	Class II	2013-05-21
K123726	Cobas 8000 Ise Indirect Na, K, Ci for Gen. 2	Roche Diagnostics GmbH	JGS	Class II	2013-05-21
K123322	Ace Bun/urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace Ck Reagent	Alfa Wassermann Diagnostics Technologies, LLC	CDN	Class II	2013-05-21
K122735	Sorin Vasculoop Two Tie Endoscopic Ligation System Model Dtts2	LivaNova USA, Inc.	GAT	Class II	2013-05-21
K122705	Humicare D900	Grundler GmbH	BTT	Class II	2013-05-21
K122519	Dio Uf Hsa Internal Sub-Merged Implant System	Dio Corporation	DZE	Class II	2013-05-21
K122214	Tg-970P Sensor Kit W/ New Airway Adapter (Yg-213T)	Nihon Kohden Corp.	CCK	Class II	2013-05-21
K130943	Aigis Rx R Pm/ Aigis Rx R Icd	Tyrx, Inc.	FTL	Class II	2013-05-20
K130457	3T Distal Coil, 3T Elbow Coil, 3T Long Bone Coil	Resonance Innovations, LLC	MOS	Class II	2013-05-20
K130146	Synthes Synflate Vertevral Balloon System	Synthes (USA) Products LLC	NDN	Class II	2013-05-20
K123428	Mirocam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2013-05-20
K123306	Nordic Tumorex	NordicNeuroLab AS	LLZ	Class II	2013-05-20
K123115	Acme Surgical Face Mask with Ear-Loop Model Yn-501 Ab/w/g/p	Acme Filter Mask Inc.	FXX	Class II	2013-05-20
K122804	Royal-Dent Eureka Dental Implant System	Intai Technology Corp.	DZE	Class II	2013-05-20
K130922	Erchonia Verju Laser System with Massager	Erchonia Medical, Inc.	OLI	Class II	2013-05-17
K130885	Magnetom Avanto-Fit, Magnetom Skyra-Fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-05-17
K130647	Xantasil Dynamix Fast Set Cartridge -2 X 380Ml; Xantasil Fast Set Cartridge -6 X 50Ml	Kulzer GmbH	ELW	Class II	2013-05-17
K130558	Somnodent Herbst; Classic, Flex	Somnomed Inc.	LRK	Class II	2013-05-17
K130533	Salto Talaris Total Ankle Prosthesis, Rhs	Tornier S.A.S.	HSN	Class II	2013-05-17
K130451	Neuroq 3.6	Syntermed, Inc.	KPS	Class II	2013-05-17
K130377	Krystalrad New Seriesdigital Radiographic Portable Retrofit System	Medicatech USA	MQB	Class II	2013-05-17
K130105	Rigidfix Curve St Acl Pla Cross Pin System, Rigidfix Curve St Acl Peek Cross Pin System	DePuy Mitek, Inc.	HTY	Class II	2013-05-17
K130037	Breathe CPAP System	Breathe Technologies, Inc.	BZD	Class II	2013-05-17
K124051	The Vault System	Somersault Orthopedics, Inc.	LLZ	Class II	2013-05-17
K124034	Mectalif Anterior	Medacta International SA	OVD	Class II	2013-05-17
K123821	Aio Hd Otoscope	Blue Focus	ERA	Class I	2013-05-17
K123603	Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime	GE Healthcare Surgery GE Oec Medical Systems, Inc.	OXO	Class II	2013-05-17
K123510	Magnetom Skyra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-05-17
K123022	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	DZE	Class II	2013-05-17
K122974	Tryout-Vps Holding Paste	Crown Delta Corp.	EMA	Class II	2013-05-17
K122417	Scopevalet Disposable Biopsy Valve	The Ruhof Corp.	OCX	Class II	2013-05-17
K121976	Aesculap Histoacryl Flexible Topical Skin Adhesive	Aesculap Inc	MPN	Class II	2013-05-17
K120750	Human Igm Csf Kit	The Binding Site Group Ltd.	CFN	Class II	2013-05-17
K120749	Human Igg Csf Kit	The Binding Site Group Ltd.	CFN	Class II	2013-05-17
K120671	Digital Pacifier Thermometer (Model No.: Tm-03)	Cotronic Technology Limited	FLL	Class II	2013-05-17
K131224	Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure	Surgical Specialties Corp. dba Angiotech	GAW	Class II	2013-05-16
K131118	4D View	GE Healthcare	LLZ	Class II	2013-05-16
K130924	Bruxzir Shaded	Prismatik Dentalcraft, Inc.	EIH	Class II	2013-05-16
K130909	Gateway Advanage Y-Adapter	Boston Scientific Corporation	OCX	Class II	2013-05-16
K130639	Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)dual Lumen Catheter	MAQUET CARDIOPULMONARY GmbH	DWF	Class II	2013-05-16
K124040	Foracare Gd20 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2013-05-16
K123736	Crystalsert Delivery System	Bausch & Lomb Incorporated	MSS	Class I	2013-05-16
K123400	Aerobika Positive Expiratory Pressure Device	Trudell Medical Intl.	BWF	Class II	2013-05-16