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 1287 of 3531

510(k) clearances, page 1287 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052548	Urok Rocking Wheelchair, Model 700-4Xx	Amg Medical Inc.	IOR	Class I	2006-01-06
K051031	Ameriwater Solution Mix and Distribution System for Hemodialysis	AmeriWater LLC.	FIN	Class II	2006-01-06
K053483	Modification to Vertex Reconstruction System	Medtronic Sofamor Danek	MNI	Class II	2006-01-05
K053324	Chromolite System	Chromogenex PLC	GEX	Class II	2006-01-05
K053299	Repicci II Onlay Unicompartmental Tibial Component	Biomet Manufacturing Corp	HRY	Class II	2006-01-05
K053285	Magbody Dt-1200, Dt-1200T, Dt-1200M, Dt-1200Pt, Dt-1200Pm	Durtech System Corp.	IPF	Class II	2006-01-05
K053272	Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves	Cardinalhealth	KGO	Class I	2006-01-05
K053209	Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System	Suntech Medical, Inc.	DXN	Class II	2006-01-05
K053136	5Th Metatarsal Fracture Screw	Wrightmedicaltechnologyinc	HWC	Class II	2006-01-05
K053101	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2006-01-05
K051847	Kd-768 Wrist Measurement Electronic Blood Pressure Monitor	Kodon(Tianjin)Electronic&Electrical Apparatus Co.	DXN	Class II	2006-01-05
K053486	Trend 200 CPAP Device, Model 5Cp201; Trendset Pc Software, Model Trendset	Hoffrichter GmbH	BZD	Class II	2006-01-04
K053347	Kodak Carestream Pacs	Eastman Kodak Company	LLZ	Class II	2006-01-04
K053168	BIPAP Focus	Respironics (Ireland) Limited	MNS	Class II	2006-01-04
K053135	Sysmex Uf-100I Automated Urine Cell Analyzer	Sysmex America, Inc.	LKM	Class II	2006-01-04
K052925	Smartprep2 Centrifuge System	Terumo BCT, Ltd	JQC	Class I	2006-01-04
K052697	Heparin/platelet Factor 4 Antibody Serum Panel	Akers Biosciences, Inc.	GGN	Class II	2006-01-04
K052301	Fastpack Tsh Immunoassay	Qualigen Inc	JLW	Class II	2006-01-04
K051990	Echelon Micro Catheter	Medtronic, Inc.	KRA	Class II	2006-01-04
K051880	Rio Aspiration Catheter	Boston Scientific Corporation	QEZ	Class II	2006-01-04
K051113	Quanta System Etrna Giovinezza	Quanta System Inc.	GEX	Class II	2006-01-04
K053530	Sonoace X4 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2006-01-03
K053065	Full Breath Sleep Appliance - Pb (Posterior Bite and Pbb (Posterior Bite with Bumps)	Bryan Keropian Dds	LQZ	Class II	2006-01-03
K052316	Powerheart Ecd	ZOLL Medical Corporation	MKJ	Class III	2006-01-03
K052272	Straumann Computer Aided Restoration Service	Straumann USA, LLC	NHA	Class II	2006-01-03
K052119	Teslaguard, Model Eft G04	Mammendorfer Institute for Physics & Medicine GmbH	MWI	Class II	2006-01-03
K051933	Expasyl Power Applicator	Sybron Dental Specialties, Inc.	ELW	Class II	2006-01-03
K051188	Grafton Dbm	Osteotech Inc	NUN	Class II	2006-01-03
K053440	Amplatzer Sizing Balloon II	Abbott Medical	MJN	Class II	2005-12-30
K053432	Ekos Micro-Infusion System	Ekos Corp.	QEY	Class II	2005-12-30
K053304	Commander III Non-Invasive Blood Pressure System	Cardiocom, LLC	DXN	Class II	2005-12-30
K053303	Cardiocom Commander III	Cardiocom, LLC	DXN	Class II	2005-12-30
K053132	Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791	FUJIFILM Healthcare Americas Corporation	JFM	Class II	2005-12-30
K053131	Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191	FUJIFILM Healthcare Americas Corporation	JFM	Class II	2005-12-30
K053020	Tnl-Ultra Assay for the Advia Centaur System	Medrad, Inc.	MMI	Class II	2005-12-30
K053016	Wireless Physiologic Monitoring System	Edwards Lifesciences LLC	DXO	Class II	2005-12-30
K052988	Caas	PIE Medical Imaging B.V.	LLZ	Class II	2005-12-30
K052862	Full Breath Sleep Appliance - Ab (Anterior Bite)	Bryan Keropian Dds	LQZ	Class II	2005-12-30
K052795	Philips Avalon Fetal Monitor, Models Fm20 and Fm30	Philips Medizin Systeme Boeblingen GmbH	HGM	Class II	2005-12-30
K052320	Encore Clp Offset Total Hip System	Encore Medical, LP	KWA	Class III	2005-12-30
K051603	Stryker Injectable Cement	Stryker Leibinger Micro Implants	MQV	Class II	2005-12-30
K053308	Abx Micros Crp 200, Option Im	Horiba Abx	GKZ	Class II	2005-12-29
K053266	Myotrac Infiniti	Thought Technology Ltd.	IPF	Class II	2005-12-29
K052972	Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3	GE Healthcare	MSX	Class II	2005-12-29
K052115	First Check Multi Drug Cup 12 for Marijuana (Thc), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy	First Check Diagnostics, LLC	DKZ	Class II	2005-12-29
K053503	Vax-D Genesis System (Therapeutic Table)	Vax-D Medical Technologies USA, L.C.	ITH	Class II	2005-12-28
K052735	Allocraft Dbm	LifeCell Corp	MBP	Class II	2005-12-28
K052725	Protector Needle Sheath Prop	Certol International, LLC	FMI	Class II	2005-12-28
K052425	Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation	Zimmer GmbH	HAW	Class II	2005-12-28
K053482	Superstitch Gw, Models 06-15-04-Gw, 08-15-04-Gw	Sutura, Inc.	GAW	Class II	2005-12-27