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 2026-10-26, 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 674 of 3530

510(k) clearances, page 674 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152536	MyOn HC Manual Wheelchair	Invacare GmbH	IOR	Class I	2016-01-05
K152498	SoloPath Re-Collapsible Access System	Onset Medical Corporation	DYB	Class II	2016-01-05
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	JXM	Class II	2016-01-05
K150459	FloSure Ventilation Patch	Simex Medizintechnik GmbH	OMP	Class II	2016-01-05
K143004	VENTURI MiNO TG600/14	Talley Group Ltd.	OMP	Class II	2016-01-05
K153052	Erchonia PL Touch	Erchonia Corporation	NHN	Class II	2016-01-04
K153037	Logiq V1/ Logiq V2	GE Healthcare	IYN	Class II	2016-01-04
K151511	ROSA Spine	MedTech LLC	OLO	Class II	2016-01-04
K151273	InMode FRF Applicator	Inmode MD, Ltd.	GEI	Class II	2016-01-04
K152746	Ez3D Plus	Ewoosoft Co., Ltd	LLZ	Class II	2016-01-03
K153208	Internal Joint Stabilizer - Elbow	Skeletal Dynamics, Inc	OZI	Class II	2015-12-31
K153094	Visions PV .035 Digital IVUS Catheter	Volcano Corporation	OBJ	Class II	2015-12-31
K152809	Giraffe Incubator Carestation CS1	GE Healthcare	FMZ	Class II	2015-12-31
K152644	Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100	Keeler Ltd.	HKY	Class II	2015-12-31
K152508	Ageless Health Medical Digital Thermometer	Dongguan Ageless Health Industrial Co., Ltd.	FLL	Class II	2015-12-31
K150585	Ascent 3D	Cao Group, Inc.	EBZ	Class II	2015-12-31
K153463	CD HORIZON Spinal System, IPC POWEREASE System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2015-12-30
K152968	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2015-12-30
K152889	Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus	Biorenew Labs, LLC	OLP	Class II	2015-12-30
K152586	Beacon Fine Needle Fiducial System	Medtronic, Inc.	NEU	Class II	2015-12-30
K152373	VITA VM LC Flow	Vita Zahnfabrik H.Rauter GmbH & Co.	EBF	Class II	2015-12-30
K152201	MedActive Oral Gel and Spray	Medactive Oral Pharmaceuticals, LLC	LFD	Unclassified	2015-12-30
K151907	Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables	Zimmer GmbH	KTT	Class II	2015-12-30
K151876	Bio2 Fusion Implant System	Bio2 Technologies, Inc.	HTY	Class II	2015-12-30
K151686	HumanPen Ergo II	Eli Lilly and Company, Pharmaceutical Delivery Systems	FMF	Class II	2015-12-30
K151255	Navigator Aesthetic Delivery System	Carticept Medical, Inc.	FRN	Class II	2015-12-30
K153053	Traxcess Pro 14 Guidewire	Terumo Cardiovascular Systems Corporation	MOF	Class II	2015-12-29
K152860	Helixar Electrosurgical Generator with Argon Beam Coagulation, Helixar Mobile Pedestal	ConMed Corporation	GEI	Class II	2015-12-29
K152112	VisualEyes	Interacoustics a/S	GWN	Class II	2015-12-29
K151025	iHearTest	Ihear Medical, Inc.	EWO	Class II	2015-12-29
K150841	Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant	Laclede, Inc.	NUC	Class II	2015-12-29
K150729	SpectraShield 9500 Surgical N95 Respirator	Nexera Medical LLC	ONT	Class II	2015-12-29
K153158	Solution Administration Sets with 0.2 Micron Filter	Baxter Healthcare Corporation	FPA	Class II	2015-12-28
K153154	Asnis JFX System	Stryker Trauma GmbH	HWC	Class II	2015-12-28
K152951	Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray	Paragon Medical Inc.	KCT	Class II	2015-12-28
K151762	PediatrOS RigidTack/FlexTack	Merete GmbH	JDR	Class II	2015-12-28
K151364	Intellijoint HIP(tm) System	Intellijoint Surgical Inc.	OLO	Class II	2015-12-28
K153492	CareView 1800L	Careray Digital Medical System Co., Ltd.	MQB	Class II	2015-12-24
K152851	BrainPort V100	Wicab, Inc.	PIC	Class II	2015-12-24
K152542	Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs	Riverstone Resources Sdn Bhd	LZA	Class I	2015-12-24
K152283	MAGNETOM Amira	Siemens Medical Solutions USA, Inc.	LNH	Class II	2015-12-24
K152162	Myray- HYPERION X5	Cefla S.C.	MUH	Class II	2015-12-24
K153071	Solitaire Platinum Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	NRY	Class II	2015-12-23
K152406	SalivaMAX	Forward Science, LLC	LFD	Unclassified	2015-12-23
K152330	Expression MR400 MRI Patient Monitoring System	Invivo Corporation	MWI	Class II	2015-12-23
K152128	2-in-1 Abdominal Muscle Training & Back Pain Relief System	Tohkai Precision Electrical Manufactory (Shenzhen) Limited	NUH	Class II	2015-12-23
K152047	INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid	Ascension Orthopedics, Inc.	KWS	Class II	2015-12-23
K151890	Medical Diode Laser Systems	Wuhan Gigaa Optronics Technology Co., Ltd.	GEX	Class II	2015-12-23
K151567	ENDOPLUS hand-held laparoscopic instruments	Endoplus	HFI	Class II	2015-12-23
K150676	L-Mesitran Dressing Family II- Soft and Tulle	Theo Manufacturing BV	FRO	Unclassified	2015-12-23