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 1302 of 3531

510(k) clearances, page 1302 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051912	Cool Line Catheter Kit, Models Cl-2085B, Cl-2295A; Icy Catheter Kit, Model Ic-3585A; Fortius Catheter Kit, Mod. Fr-5093B	Alsius Corp.	NCX	Class II	2005-10-11
K051680	Dynatron Dx2 Traction Unit	Dynatronics Corp.	ILY	Class II	2005-10-11
K050373	Unicap Unicompartmental Knee Resurfacing Prosthesis	Arthrosurface, Inc.	HSX	Class II	2005-10-11
K052792	Anthology Hip Stem	Smith & Nephew, Inc.	JDI	Class II	2005-10-07
K052640	Gemini Raptor	Philips North America LLC	KPS	Class II	2005-10-07
K052621	1.5T 16 Channel Brain-Spine Array Coil	GE Healthcare Coils	MOS	Class II	2005-10-07
K052584	1.5T 12 Channel Body Array	GE Healthcare Coils	MOS	Class II	2005-10-07
K052538	S-Bone Hip Tool	Orthopedic Sciences, Inc	HRS	Class II	2005-10-07
K052491	Axya Model 6500 Axyaloop Self-Tapping Bone Anchor	TORNIER Inc.	MBI	Class II	2005-10-07
K052486	Proasia, Model L4501	Proasia Limited	INI	Class II	2005-10-07
K052390	Synthes Lcp Proximal Tibia Plates Line Extension	Synthes (USA) Products LLC	HRS	Class II	2005-10-07
K052384	Lanx Vbr System	Lanx, LLC	MQP	Class II	2005-10-07
K052378	Proasia, Model L3402	Proasia Limited	INI	Class II	2005-10-07
K052341	Ajex 9015/135H Portable X-Ray	Jpi America, Inc.	IZL	Class II	2005-10-07
K052312	Wide 5Mp (Mammo) Lcd Monitor System	Wide Corporation	LLZ	Class II	2005-10-07
K052261	Modification to: Verte-Stack Spinal System	Medtronic Sofamor Danek USA Inc	MQP	Class II	2005-10-07
K052183	Soring Gmbh Sonoca Lipo	Soring GmbH Medizintechnik	QPB	Class II	2005-10-07
K051950	Inscope Multi-Clip Applier, Models In22321, In23321	Ethicon Endo-Surgery Inc	MND	Class II	2005-10-07
K051869	Neoblue Cozy LED Phototherapy System	Bio-Logic Systems Corp.	LBI	Class II	2005-10-07
K051844	Equator Plus Acetabular Cup System	Portland Orthopaedics Pty., Ltd.	MAY	Class II	2005-10-07
K051742	Oocyte Retrieval Needle Set, Models 917-Ih and 917-Sh	Inntec, Inc.	MQE	Class II	2005-10-07
K051646	Ise Diluent, 1N Kcl, Internal Reference and Ise Standards Low and High	Horiba Instruments Incorporated	JGS	Class II	2005-10-07
K051607	Novaspine Cement Restrictor Nscr	Novaspine, LLC	JDK	Class II	2005-10-07
K051544	Vitalcaregiving System	Advanced Monitoring Caregiving, Inc.	DXH	Class II	2005-10-07
K051066	Theratest El-Ana Profiles	Theratest Laboratories, Inc.	LKP	Class II	2005-10-07
K051044	Arctec Semirigid Plating System	Altiva Corp.	MNH	Class II	2005-10-07
K050997	Expanse Vertebral Body Replacement Device	Flexuspine, Inc.	MQP	Class II	2005-10-07
K050985	Glucodr Supersensor System	All Medicus Co., Ltd.	NBW	Class II	2005-10-07
K052681	Start Family of Manual Wheelchairs (Basic, Plus, Multi and Hemi)	Otto Bock Healthcare LP	IOR	Class I	2005-10-06
K052549	Leadcare II Blood Lead Testing System	Magellan Diagnostics, Inc.	DOF	Class II	2005-10-06
K052506	Rubicor Encapsule Breast Biopsy Device, Model 31108	Rubicor Medical, Inc.	GEI	Class II	2005-10-06
K052472	Depuy Global Shoulder Crosslink Glenoid	Depuy Orthopaedics Inc.	KWS	Class II	2005-10-06
K052436	Pleurx Pleural Catheter Kit, Model 50-7000	Denver Biomedical, Inc.	DWM	Class II	2005-10-06
K052141	Stryker Stiletto Electrosurgical Probe	Stryker Corp.	GEI	Class II	2005-10-06
K051987	Flexiskin Polymer Coated Latex Examination Gloves, Powder Free, Non-Sterile	Pt. Mandiri Inti Buana	LYY	Class I	2005-10-06
K051584	14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets Accessory	Kendall	MSD	Class II	2005-10-06
K043213	Kowa Vx-10	Kowa Co., Ltd.	HKI	Class II	2005-10-06
K052686	Arthrocare Arthrowands	ArthroCare Corporation	GEI	Class II	2005-10-05
K052626	Smartsuction Harmony Device	Haemonetics Corporation	BTA	Class II	2005-10-05
K052468	Yk9000 Series Manual Wheelchair	Intco Metal Products (Zhenjiang) Co., Ltd.	IOR	Class I	2005-10-05
K052367	Scient'x Cement Restrictor	Scient'X	JDK	Class II	2005-10-05
K052358	Etiam Star Pacs Components	Etiam, S.A.	LLZ	Class II	2005-10-05
K052270	Bd Phoenix Automated Microbiology System - Cefuroxime (Strep) 0.125 - 4Ug/ml	Becton Dickinson & Co	LON	Class II	2005-10-05
K051879	Synthes (USA) Porous Polyethylene Implants	Synthes (USA) Products LLC	FTM	Class II	2005-10-05
K051632	Philips Heartstart Fr2+ Automated External Defibrillator, Models M3860a, M3861a, M3840a, M3841a	Philips North America LLC	MKJ	Class III	2005-10-05
K051534	Cardioline Ar 600, Ar 1200, Ar 2100	Et Medical Devices SpA	DPS	Class II	2005-10-05
K051508	Med Flash II Intense Pulsed Light System.	General Project S.r.l.	GEX	Class II	2005-10-05
K051176	Flexible Video Cystoscope/choledochoscope, Models 7308.061 and 7308.066	Richard Wolf Medical Instruments Corp.	FAJ	Class II	2005-10-05
K052585	3T Hd Breast Array	GE Healthcare Coils	MOS	Class II	2005-10-04
K052430	Cardius-1, Cardius-2, Cardius-3, 2020Tc Spect Imaging System	Digirad Corp.	KPS	Class II	2005-10-04