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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 455 of 3528

510(k) clearances, page 455 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191611	Diode Laser Therapy Systems	Wingderm Electro-Optics Ltd.	GEX	Class II	2019-07-31
K191510	Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae	Hycor Biomedical	DHB	Class II	2019-07-31
K191183	EyeBOX	Oculogica Inc.	QEA	Class II	2019-07-31
K190891	Fluobeam LX	Fluoptics	QDG	Class II	2019-07-31
K190777	DemeTECH DemeFORCE Nonabsorbable Surgical Suture	Demetech Corp.	GAT	Class II	2019-07-31
K190732	P200TxE	Optos PLC.	OBO	Class II	2019-07-31
K190672	StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1	Medtronic Navigation, Inc	HAW	Class II	2019-07-31
K191768	AXS Vecta Aspiration System	Stryker Corp.	NRY	Class II	2019-07-30
K191484	Renuvion/J-Plasma Precise Handpiece	Apyx Medical Corporation (Formerly Bovie Medical Corporation	GEI	Class II	2019-07-30
K191454	Atellica CH Amylase_2 (AMY_2)	Siemens Healthcare Diagnostics Inc.	JFJ	Class II	2019-07-30
K190291	Addivation Medical Cervical Interbody System	Addivation Medical	ODP	Class II	2019-07-30
K190274	Endotracheal Tube	Tianjin Medis Medical Device Co., Ltd.	BTR	Class II	2019-07-30
K190132	Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter	Medtronic, Inc.	DRF	Class II	2019-07-30
K183547	Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter	Medtronic, Inc.	DRF	Class II	2019-07-30
K183288	Transcutaneous Electrical Nerve Stimulator	Shenzhen Kentro Medical Electronics Co., Ltd	NUH	Class II	2019-07-30
K182089	Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs	Platinum Glove Industries Sdn. Bhd.	LZA	Class I	2019-07-30
K181754	Blood Collection Accessory (BUCA)	NSP Tech Pte Ltd	JKA	Class II	2019-07-30
K181743	Blood Transfer Accessory (BTA)	NSP Tech Pte Ltd	JKA	Class II	2019-07-30
K180295	Hamilton-G5	Hamiton Medical AG	CBK	Class II	2019-07-30
K191797	BiomarC Fiducial Marker	Carbon Medical Technologies, Inc.	IYE	Class II	2019-07-29
K191535	CoLink® Mini Plating System	In2bones USA, LLC	HRS	Class II	2019-07-29
K191398	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System	Zeus Scientific LLC	LSR	Class II	2019-07-29
K191289	Bone Screw Line Addition	Vilex LLC	HWC	Class II	2019-07-29
K191240	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System	Zeus Scientific LLC	LSR	Class II	2019-07-29
K191154	Hair Boom 69	WONTECH Co., Ltd.	OAP	Class II	2019-07-29
K191136	Access CT	Philips Healthcare (Suzhou) Co., Ltd.	JAK	Class II	2019-07-29
K190907	ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System	Zeus Scientific LLC	LSR	Class II	2019-07-29
K190886	Non-invasive blood pressure measurement systems	Joytech Healthcare Co., Ltd.	DXN	Class II	2019-07-29
K190809	Sample Imaging for Senographe Pristina	GE Healthcare	MUE	Class II	2019-07-29
K190569	Shaders ZR	Digital Age Dental Lab	EIH	Class II	2019-07-29
K190339	Helioseal F Plus	Ivoclar Vivadent, Inc.	EBC	Class II	2019-07-29
K183048	Quantisal II Oral Fluid Collection Device	Immunalysis Corporation	PJD	Class II	2019-07-29
K190996	Bonus Therapeutics Mixing and Delivery System	Bonus Therapeutics, Ltd.	FMF	Class II	2019-07-28
K191817	ActivOrtho Continuous Compression Screw System	Activortho, Inc.	HWC	Class II	2019-07-26
K191777	Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition	GE Healthcare	JAK	Class II	2019-07-26
K191736	da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30	Intuitive Surgical, Inc.	NAY	Class II	2019-07-26
K191733	The ZIP Accessory Shuttle for PleuraFlow System	Clearflow, Inc	OTK	Class II	2019-07-26
K191714	ASAHI Neurovascular Guide Wire CHIKAI X 014 soft	Asahi Intecc Co., Ltd.	MOF	Class II	2019-07-26
K191396	Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe	Horiba Abx SAS	CJY	Class II	2019-07-26
K191328	Megadyne Foot Switch	Megadyne Medical Products, Inc	FYD	Class II	2019-07-26
K190949	ScanX Barrier Envelopes	Air Techniques, Inc.	PEM	Class II	2019-07-26
K190873	Infrared Ear/Forehead Thermometer	Joytech Healthcare Co., Ltd.	FLL	Class II	2019-07-26
K190685	Hair Growth System	Xuzhou Kernel Medical Equipment Co Ltd	OAP	Class II	2019-07-26
K190533	Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented	SleepNet Corporation	CBK	Class II	2019-07-26
K190062	STATCLAVE G4 Chamber Autoclave	Scican Ltd.	FLE	Class II	2019-07-26
K183486	RapidVit™ Oocyte, RapidWarm™ Oocyte	Vitrolife Sweden AB	MQL	Class II	2019-07-26
K183280	PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs	Smart Glove Corporation Sdn. Bhd.	LZA	Class I	2019-07-26
K183271	AI-Rad Companion (Pulmonary)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2019-07-26
K183194	Arthrex Eclipse Shoulder Prosthesis System	Arthrex GmbH	QHQ	Class II	2019-07-26
K183129	Medtronic Total Hip Arthroplasty System	Medtronic Navigation, Inc	LPH	Class II	2019-07-26