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 846 of 3530

510(k) clearances, page 846 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122456	Mrii Crainial Drill	Mri Interventions, Inc.	HBG	Class II	2013-03-22
K122253	Procare Monitor B20	GE Medical Systems China Co., Ltd.	MHX	Class II	2013-03-22
K122037	Anatomic Peek Cervical Fusion System Cornerstone Psr Cervical Fusion System Peek Prevail Cervical Interbody Device Capst	Medtronic Sofamor Danek	MAX	Class II	2013-03-22
K121946	Axis-Shield Acvtive-B12	Axis-Shield Diagnostics, Ltd.	CDD	Class II	2013-03-22
K121247	Alco-Screen	Chematics, Inc.	DIC	Class II	2013-03-22
K120771	Unicel Dxh 800 Coulter Cellular Analysis System	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2013-03-22
K130619	Acuson S1000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2013-03-21
K130609	Veeda 100% Cotton Menstrual Tampon	Naturalena Brands, Inc.	HEB	Class II	2013-03-21
K130413	Pinpointe Footlaser	Nuvolase, Inc.	GEX	Class II	2013-03-21
K130344	Dornier Medilas Uropulse	Dornier Medtech America, Inc.	GEX	Class II	2013-03-21
K130221	Hero II Dental Implant System, Ui Dental Implant System	Medimecca Co Ltd	DZE	Class II	2013-03-21
K130112	Capno Module, 92517	GE Healthcare	CCK	Class II	2013-03-21
K123511	S9 Vpap Tx	ResMed Corp	MNS	Class II	2013-03-21
K123498	Bp652n (Hem-6300-Z)	Omron Healthcare Co., Ltd.	DXN	Class II	2013-03-21
K123335	Sunray Fetal Monitor	Sunray Medical Apparatus Co., Ltd.	HGM	Class II	2013-03-21
K122218	Advance Total Knee System-Patella	Wrightmedicaltechnologyinc	MBH	Class II	2013-03-21
K122206	Garaventa X3 Inclined Platform Lift	Garaventa (Canada) Ltd [dba Garaventa Lift]	PCE	Class II	2013-03-21
K122098	Apps-Health01	Andon Health Co., Ltd	DXN	Class II	2013-03-21
K122060	Clever Td-7001Nebulizer	Taidoc Technology Corporation	CAF	Class II	2013-03-21
K121981	Advia Centaur Inact Parathyroid Hormone (Ipth) Assay	Siemens Healthcare Diagnostics Inc.	CEW	Class II	2013-03-21
K121979	Pass Oct Spinal System	Medicrea International	KWP	Class II	2013-03-21
K121894	Xtag Gastrointestinal Pathogen Panel(gpp) Xtag Data Analysis Software for Gpp (Tdas Gpp) Luminex Magpix	Luminex Molecular Diagnostics Inc	PCH	Class II	2013-03-21
K121772	Allura 3D-Ra Rel 6, 3D Roadmap Rel 1, Mr-CT Roadmap Rel 1	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-03-21
K120354	Beta-Tcp Granules	Skeletal Kinetics, LLC	MQV	Class II	2013-03-21
K113727	Shenzhen Med-Link Pulse Oximeter Probe	Shenzhen Med-Link Electronics Tech Co.,Ltd	DQA	Class II	2013-03-21
K130433	Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate	Corcym Inc.	DTZ	Class II	2013-03-20
K130393	Mirada Rtx	Mirada Medical Limited	LLZ	Class II	2013-03-20
K130257	Cps Direct Universal Slittable Outer Catheter	Abbott Medical	DQY	Class II	2013-03-20
K130252	Cps Aim Universal Slittable Inner Catheter	Abbott Medical	DQY	Class II	2013-03-20
K130247	Pentax Eg-3870Utk Ultrasound Video Gastroscope + Hi Vision Preirus	PENTAX of America, Inc.	ODG	Class II	2013-03-20
K130229	Palm Bladder Scanner	Mianyang Meike Electronic Equipment Co.,Ltd.	IYO	Class II	2013-03-20
K130228	Suiteheart	Neosoft, LLC	LLZ	Class II	2013-03-20
K130206	Pentax Eg-3670Urk Ultrasound Video Gastroscope + Hi Vision Preirus	PENTAX of America, Inc.	ODG	Class II	2013-03-20
K123952	Cerec Blocs C in	Sirona Dental Systems GmbH	EIH	Class II	2013-03-20
K123832	Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle Plating System, the Oic Small Fragme	The Orthopaedic Implant Company (Oic)	HRS	Class II	2013-03-20
K123805	E-Z Chek Blood Leak Test Strips	Reprocessing Products Corp	FJD	Class II	2013-03-20
K123687	Optetrak Logic Porous Femoral Component	Exactech, Inc.	JWH	Class II	2013-03-20
K123640	Tx1 Tissue Removal System	Tenex Health	LFL	Unclassified	2013-03-20
K123468	Demi Ultra	Sybron Dental Specialties, Inc.	EBZ	Class II	2013-03-20
K123403	Axsos Proximal Lateral Tibia Long Plates	Stryker Trauma GmbH	HRS	Class II	2013-03-20
K122247	Lidcorapid V2 Monitor	Lidco Ltd	DXG	Class II	2013-03-20
K122160	Vanguard Xp Knee System	Biomet Manufacturing Corp	MBH	Class II	2013-03-20
K121655	Bd Alcohol Swab	Becton Dickinson & Co	LKB	Unclassified	2013-03-20
K120782	Interventional Hemostatic Bandage	Z-Medica, LLC	QSY	Unclassified	2013-03-20
K130468	Orbit Infusion Set	Ypsomed AG	FPA	Class II	2013-03-19
K130157	Audit Microcv Beta-Hydroxybutyric Acid Linearity Set	Aalto Scientific Ltd.	JJX	Class I	2013-03-19
K123765	Guidezilla Guide Extension Catheter	Boston Scientific Corporation	DQY	Class II	2013-03-19
K123589	Cadwell Disposable Probe Handle	Cadwell	PDQ	Class II	2013-03-19
K123477	Via Microcatheter, via Plus Microcatheter	Sequent Medical, Inc.	KRA	Class II	2013-03-19
K123415	Biodenta Dental Implant System- Bone Level Tapered	Biodenta Swiss AG	DZE	Class II	2013-03-19