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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1240 of 3531

510(k) clearances, page 1240 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052544	Pulse Oximeter Adapter Cables	American I.V. Products, Inc.	DQA	Class II	2006-09-29
K062610	Care-E-Vac 3	Ohio Medical LLC	BTA	Class II	2006-09-28
K062514	Cyberknife Robotic Radiosurgery System	Accuray Incorporated	MUJ	Class II	2006-09-28
K062451	Neuviz Dual Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2006-09-28
K062401	Modification to Lucas	Jolife AB	DRM	Class II	2006-09-28
K062396	Modification to Stockert S5 System	LivaNova Deutschland GmbH	DTQ	Class II	2006-09-28
K062071	Prometey, Model G1-03	Spectrum International	GEX	Class II	2006-09-28
K061906	Clearfil Ceramic Primer	Kuraray Medical, Inc.	EBF	Class II	2006-09-28
K061856	V-2200 Infant Incubator	Atom Medical Corporation	FMZ	Class II	2006-09-28
K061768	Mp-1 Microperimeter	Nidek Technologies SRL	HKI	Class II	2006-09-28
K061548	Stryker Ureteral Illumination System IV	Stryker Corp.	FCS	Class II	2006-09-28
K060482	Cytori Celution Cell Concentration Device	Cytori Therapeutics, Inc.	CAC	Class II	2006-09-28
K062758	Owl Urf-3Ap	Diros Technology, Inc.	GXD	Class II	2006-09-27
K062679	Arthrex Corkscrew Ft III Suture Anchor with Three #2 Sutures	Arthrex GmbH	HWC	Class II	2006-09-27
K062599	Monitorr Icp External Drainage and Monitoring Systems	Integra LifeSciences Corporation	JXG	Class II	2006-09-27
K062429	Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh	Edwards Lifesciences LLC	DTM	Class II	2006-09-27
K062385	Blue PTFE (Fluoroplastic) Ventilation Tubes	Grace Medical, Inc.	ETD	Class II	2006-09-27
K062382	Clearfil Dc Bond	Kuraray Medical, Inc.	KLE	Class II	2006-09-27
K062356	Kowa Nonmyd Alpha-D	Kowa Co., Ltd.	HKI	Class II	2006-09-27
K062252	Molteno3	Iop, Inc.	KYF	Class II	2006-09-27
K062031	Chase Cardiac Analysis System	Chase Medical, Inc.	LLZ	Class II	2006-09-27
K061976	Ckis-004A Injector Synchronization Option	Toshiba America Medical Systems, In.C	DXT	Class II	2006-09-27
K061966	Litetouch Dental Laser System	Light Instrument, Ltd.	GEX	Class II	2006-09-27
K061597	Epoc Blood Analysis System	Epocal Inc	JGS	Class II	2006-09-27
K060787	Tattoostar Family	Asclepion Laser Technologies GmbH	GEX	Class II	2006-09-27
K062505	Nex-Link Spinal Fixation System Offset Connectors, 2121-Xx Series	Spinal Concepts, Inc.	MNI	Class II	2006-09-26
K062410	Clearfil Esthetic Cement & Dc Bond	Kuraray Medical, Inc.	EMA	Class II	2006-09-26
K062133	Modification to Verte-Stack Spinal System	Medtronic Spinal and Biologics Div	MQP	Class II	2006-09-26
K061524	Iss Integrated Spine System	Ortho Development Corp.	MNH	Class II	2006-09-26
K060847	Magstim 200-2	Magstim Company Us, LLC	GWF	Class II	2006-09-26
K062701	Quickie Rhapsody, Mwd Series II Power Wheelchair	Sunrise Medical, Inc.	ITI	Class II	2006-09-25
K062606	Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2006-09-25
K062342	Truepulse Disposable Invasive Blood Pressure Monitoring Kit	Sentra Medical Devices, LLC	DRS	Class II	2006-09-25
K062210	Cool Touch, Models Ct3s, Ctev, Ns160, Ctev, Lc160	New Star Lasers, Inc.	GEX	Class II	2006-09-25
K062000	Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model Wave18s; Harmonic Disposable Torque Wrench	Ethicon Endo-Surgery Inc	LFL	Unclassified	2006-09-25
K061967	Scd Garment, Model Vp530	Compression Therapy Concepts, Inc.	JOW	Class II	2006-09-25
K061949	Doubleplay Suture Anchor	Biocomposites, Ltd.	HWC	Class II	2006-09-25
K061776	Arthrotek Maxfire Meniscal Repair Device	Arthrotek, Inc.	JDR	Class II	2006-09-25
K061770	Ethicon Endo Surgery Endoscopic Suturing System	Ethicon Endo-Surgery Inc	OCW	Class II	2006-09-25
K061618	Cooltouch, Model Ctev	New Star Lasers, Inc.	GEX	Class II	2006-09-25
K061422	Surgical Drapes	Austin Medical, Inc.	KKX	Class II	2006-09-25
K061340	23 Mm Single-Peg Patella Component	Biomet Manufacturing Corp	JWH	Class II	2006-09-25
K062673	Modification to Syngo Inspace 4D	Siemens AG Medical Solutions	JAK	Class II	2006-09-22
K062618	Trilogy Tx with 3Rd Party Couch Top Support	Varian Medical Systems, Inc.	IYE	Class II	2006-09-22
K062531	Angioguard Xp Emboli Capture Guidewire and Angioguard Rx Emboli Capture Guidewire	Cordis Corp., A Johnson & Johnson Co.	NTE	Class II	2006-09-22
K062334	Dimension Vista Chemistry 3 Calibrator, Model Kc130	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-09-22
K062204	Architect Cortisol Assay	Seradyn, Inc.	JFT	Class II	2006-09-22
K062164	Resolutionmd, Version 1.3	Calgary Scientific, Inc.	LLZ	Class II	2006-09-22
K062163	Mimviewer	MIM Software Inc	LLZ	Class II	2006-09-22
K062119	Hlr Model 601 Heart Lung Resuscitator and Heartsaver 100	Medical Products Mfg., LLC	DRM	Class II	2006-09-22