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 921 of 3530

510(k) clearances, page 921 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113683	Lifeshield Vision Infusion Set with Pre-Pierced Reseal	Abbott Medical	FPA	Class II	2012-01-12
K113679	Lucea LED Surgical Light System	Maquet SAS	NTN	Class II	2012-01-12
K113667	Cardioplegia Delivery Sets Cardioplegia Delivery Sets with Duraflo Coating	Edwards Lifesciences LLC	DTL	Class II	2012-01-12
K113654	Caspian	K2M, Inc	KWP	Class II	2012-01-12
K113330	Cablecap	Sensormed	FST	Class II	2012-01-12
K113318	Acute Innovations Modular Ribloc System	Acute Innovations, LLC	HRS	Class II	2012-01-12
K113123	Oic Cannulated Screw System, Oic Sliding Hip Screw (Shs) System	The Orthopaedic Implant Company	KTT	Class II	2012-01-12
K113085	Tryly Automatic Wrist Blood Pressure Monitor	Truly Instrument Limited	DXN	Class II	2012-01-12
K111992	Curos Port Protector	Ivera Medical, Inc.	QBP	Class II	2012-01-12
K110888	Absolute White Light	Dr. Fresh, Inc.	EEG	Class I	2012-01-12
K102439	Funnel Guide Catheter Model G1020608	Lazarus Effect, Inc.	DQY	Class II	2012-01-12
K100437	Ap-1000 Blood Glucose Monitoring System, Model Ap-1000, Major Glucose Control Solution	Bestgen Biotech Corp.	NBW	Class II	2012-01-12
K113681	Gladiator Pta Balloon Dilation Catheter	Boston Scientific Corporation	LIT	Class II	2012-01-11
K113651	Interlock-35 Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2012-01-11
K113460	Synergy Tissue Matrix	Synovis Orthopedic & Woundcare	FTM	Class II	2012-01-11
K113405	Suspension Clavicle Fracture Repair System	Suspension Orthopaedic Solutions, LLC	HRS	Class II	2012-01-11
K113069	Comprehensive Reverse Shoulder Humeral Tray	Biomet Manufacturing Corp	PHX	Class II	2012-01-11
K112811	Saniclave 200	Alternative Pioneering Research and Development	FLE	Class II	2012-01-11
K112256	Steris Steam Pi	STERIS Corporation	JOJ	Class II	2012-01-11
K111794	Reprocessed Harmonic Scalpel	Sterilmed Inc	NLQ	Unclassified	2012-01-11
K113758	Voluson E6/e8/e8expert/e10	GE Healthcare	IYE	Class II	2012-01-10
K113625	Dss Stabilization System	Paradigm Spine GmbH	NKB	Class II	2012-01-10
K113351	Cortrak Enteral Access Device	Halyard Health	KNT	Class II	2012-01-10
K113138	Aleutian System	K2M, Inc	MAX	Class II	2012-01-10
K112332	Fine Ject Insulin Pen Needle	Twobiens Co., Ltd.	FMI	Class II	2012-01-10
K111761	Neo Titanium Mesh, Cti-Mem	Neobiotech Co., Ltd.	JEY	Class II	2012-01-10
K111623	I-Endo Dual	Satelec-Acteon Group	EBW	Class I	2012-01-10
K110971	Tracer Implantation Kit, Index Implantation Kit	Navotek Medical, Ltd.	IYE	Class II	2012-01-10
K110581	Propatch Soft Tissue Repair Matrix	Artivion, Inc.	FTM	Class II	2012-01-10
K103695	Prepex System	Circ Medtech	HFX	Class II	2012-01-10
K113071	Synthecel Dura Replacement Devices	Synthes GmbH	GXQ	Class II	2012-01-09
K112960	Labralink Suture Anchor with Inserter, 2.9Mm per-Loaded with One (1) and (2) #2 Uhmwpe Suture	Cayenne Medical Inc.	MBI	Class II	2012-01-09
K112514	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	MNR	Class II	2012-01-09
K112258	Neurotech Plus	Bio-Medical Research, Ltd.	GZJ	Class II	2012-01-09
K113477	Ivas 20Mm (10 Gauge) Balloon Catheter	Stryker Corp.	NDN	Class II	2012-01-06
K113159	U-Right Td-1240 Thermometer	Taidoc Technology Corporation	FLL	Class II	2012-01-06
K113137	Glucose Test System	Roche Diagnostics GmbH	NBW	Class II	2012-01-06
K113127	Mirage Quattro	ResMed Corp	BZD	Class II	2012-01-06
K112523	Immulite 2000 3Gallergy Specific Ige Assay Kit	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2012-01-06
K112301	Zimmer Patient Specific Instruments Planner	Materialise N.V.	HSX	Class II	2012-01-06
K112169	Aptus Wrist Arthrodesis Plates	Medartis AG	HRS	Class II	2012-01-06
K112060	Radiance	Gmv Aerospace and Defence S.A.	MUJ	Class II	2012-01-06
K112046	Mta Angelus	Angelus Industria de Productos Odontologicos	KIF	Class II	2012-01-06
K112008	Touchpacs Suite	Touch Medical Solutions, Inc.	LLZ	Class II	2012-01-06
K111861	Syngo.mr Onco, Syngo.mr 3D Lesion Segmentation, Syngo.mr Onco Engine	Siemens Medical Systems USA, Inc.	LLZ	Class II	2012-01-06
K111730	Sonott Flowlab(r)	Em-Tec GmbH	DPW	Class II	2012-01-06
K111165	Karl Storz Scb / Covidien Forcetriad Interface Module	Karl Storz Endoscopy-America, Inc.	ODA	Class II	2012-01-06
K110559	Avita Infrared Therometer with Bluetooth	Avita Corporation	FLL	Class II	2012-01-06
K113708	Orthoscan Mobile Di Mini C-Arm	Orthoscan, Inc.	OXO	Class II	2012-01-05
K113638	Nmi 2.8 Microcatheter	Boston Scientific Corporation	DQO	Class II	2012-01-05