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 877 of 3530

510(k) clearances, page 877 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122563	Myosure Xl Rod Lens Hysteroscope, Myosure Xl Outlfow Channel	Hologic, Inc.	HIH	Class II	2012-09-19
K122514	Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid Test	Luminex Corporation	PAM	Class II	2012-09-19
K121917	Penumbra Embolectomy Aspiration System	Penumbra Inc.	QEW	Class II	2012-09-19
K121689	Vitascan Lt Scanmaster	Vitacon Medical, Inc.	IYO	Class II	2012-09-19
K121302	Biomet Microfixation Sternal Closure System	Biomet Microfixation	HRS	Class II	2012-09-19
K121224	Genesis Health Technologies Blood Glucose Monitoring System	Taidoc Technology Corporation	LFR	Class II	2012-09-19
K121055	Mets Modular Total Femur	Stanmore Implants Worldwide, Ltd.	JDI	Class II	2012-09-19
K121029	Mets Modular Distal Femur	Stanmore Implants Worldwide, Ltd.	KRO	Class II	2012-09-19
K120968	Power-Free Vinyl Patient Examination Gloves, Clear(non-Colored)	Tangshan Zhonghong Pulin Plastic Co.,Ltd	LYZ	Class I	2012-09-19
K120657	Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors	Masimo Corporation	DQA	Class II	2012-09-19
K120644	Merit Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2012-09-19
K120450	Sleep Profiler	Advanced Brain Monitoring, Inc.	OLZ	Class II	2012-09-19
K120405	Walk on Wheels Hs-3500 Electric Aisle Wheelchair	Walk on Wheels Australia Pty, Ltd.	ITI	Class II	2012-09-19
K120397	Meb-2300A Neuropack Evoked Potential and EMG Measuring System	Nihon Kohden Corp.	GWF	Class II	2012-09-19
K120288	Orthocad Software Option	Esaote S.p.A.	LLZ	Class II	2012-09-19
K120018	Mindchild Meridian Fetal Heart Rate Monitor	Mindchild Medical	HGM	Class II	2012-09-19
K122591	Clydesdale Spinal System	Medtronic Sofamor Danek	MAX	Class II	2012-09-18
K121633	Bd Veritor(tm) System for the Rapid Detection of Rsv	Becton Dickinson & Co	GQG	Class I	2012-09-18
K121614	Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter	Boston Scientific Corporation	LJE	Unclassified	2012-09-18
K121519	Isight	C&E GP Specialists, Inc.	LPL	Class II	2012-09-18
K120107	Sckooncup	Sckoon, Inc.	HHE	Class II	2012-09-18
K110949	Bicera (Tm) Resorbable Bone Substitute	Wiltrom Corporation Limited	MQV	Class II	2012-09-18
K122506	Surefire High Flow Angiographic Catheter, Access	Surefire Medical, Inc.	DQX	Class II	2012-09-17
K122487	Biofiber Syture	TORNIER Inc.	NWJ	Class II	2012-09-17
K121187	Katalyst Laser Probes, Katalyst Illuminated Laser Probes	Katalyst Surgical, LLC	HQF	Class II	2012-09-17
K121114	Tigran Peribrush	Tigran Technologies AB	ELB	Class II	2012-09-17
K121022	Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote with Resistiv	AmeriWater LLC.	FIP	Class II	2012-09-17
K120328	Origins Lipoharvesting System	Solta Medical, Inc.	MUU	Class II	2012-09-17
K120281	Dignity Power Injectable Titanium Port	Medical Components, Inc.	LJT	Class II	2012-09-17
K120235	Model Family of Aerolase Nd:yag Lasers: Friendlylight Nd: Yag Lasers, Friendlylight Neo, Lightpod Nd: Yag Lasers, Lightp	Aerolase Medical Lasers, LLC	GEX	Class II	2012-09-17
K113742	Kmc Kyphoplasty System	SHANGHAI KiNETIC MEDICAL CO Ltd	NDN	Class II	2012-09-17
K121694	Imager II Angiographic Catheter	Boston Scientific Corporation	DQO	Class II	2012-09-14
K121625	Lullaby Tm Warmer	Wipro GE Healthcare Private Ltd.	FMT	Class II	2012-09-14
K121575	Oxford Ankle Fusion Nail(afn) System	Ortho Solutions Inc	HSB	Class II	2012-09-14
K121439	Metafix Femoral Hip Stem Size 1	Corin USA	LZO	Class II	2012-09-14
K121153	Peek Customized Craial Implant Kit	Stryker Corp.	GWO	Class II	2012-09-14
K120825	Supra Scan Delivery System	Quantel Medical	HQF	Class II	2012-09-14
K113296	Zmr Hip System Kwz-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/polymer	Zimmer GmbH	LPH	Class II	2012-09-14
K111375	Sterrad (R) Cyclesure (R) 24 Biological Indicator	Advanced Sterilization Products	FRC	Class II	2012-09-14
K110053	Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit	Abbott Medical	CAZ	Class II	2012-09-14
K100645	Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface	Medtronic, Inc.	DTZ	Class II	2012-09-14
K122593	Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2	Optim LLC	FEH	Class II	2012-09-13
K122579	Velashape	Syneron Medical, Ltd.	NUV	Class II	2012-09-13
K122491	Viamo Ssa-640A V4.0	Toshibamedical Systems Corporation	IYN	Class II	2012-09-13
K122413	Patient Positioning System	Forte Automation Systems, Inc.	JAI	Class II	2012-09-13
K122119	Dx-D Full Leg Full Spine	Afga Healthcare N.V.	KPR	Class II	2012-09-13
K122019	Streptococcus App. Serological Reagents	Meridian Bioscience Inc	OYZ	Class I	2012-09-13
K121827	Gsi Viewer with Vue Option	GE Medical Systems SCS	JAK	Class II	2012-09-13
K121774	Rotablator Rotational Atherectomy System with Peripheral Rotalink Plus	Boston Scientific Corporation	MCW	Class II	2012-09-13
K121541	Jazz System	Implanet	JDQ	Class II	2012-09-13