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 895 of 3530

510(k) clearances, page 895 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120871	Smith & Nephew, Inc. External Fixation System Instrumentation	Smith & Nephew, Inc.	JDW	Class II	2012-06-07
K120841	Appianfx Suture Anchor (6Mm) (5Mm) Appianfx Tissue Anchor	Kfx Medical	MBI	Class II	2012-06-07
K120808	Export Xt Catheter, Export Ap Catheter	Medtronic, Inc.	QEZ	Class II	2012-06-07
K120646	Capsure(r) Ps System	Spine Wave Inc	MNI	Class II	2012-06-07
K112607	Spinevision Lumis(tm) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.l.i.s.(tm) Polyaxial Pedicle ...	Spinevision Inc.	NKB	Class II	2012-06-07
K112090	Bahadir Sterilization Trays	Bahadir USA LLC	KCT	Class II	2012-06-07
K121507	Atricure Cryo Module System (Acm, Cryo1, and Cryoice)	AtriCure, Inc.	GEH	Class II	2012-06-06
K121480	Ariatele Telemetry Transmitter (96281)	GE Healthcare	MHX	Class II	2012-06-06
K121318	Prosoft	Perma Laboratories	EBP	Class II	2012-06-06
K121131	Bl, 04.1 Mm Rc, Slactive 8Mm, Tizr and 10Mm, 12, 14Mm	Straumann USA, LLC	DZE	Class II	2012-06-06
K121128	Multipurpose Handling Medium	FUJIFILM Biosciences Inc.	MQL	Class II	2012-06-06
K121094	Medcomp Vascu-Picc & Midline Catheters	Medical Components, Inc.	LJS	Class II	2012-06-06
K121064	Makoplasty Total Hip Application, Rio Standard System	Mako Surgical Corp.	OLO	Class II	2012-06-06
K120987	Dlp Single Stage Venous Cannula Inflatable Cuff	Medtronic, Inc.	DWF	Class II	2012-06-06
K120852	Zirconia Blanks (Zircostar)	Kerox, Ltd.	EIH	Class II	2012-06-06
K120731	Titanium Fletcher-Style Applicator Set-Defined Geometry	Varian Medical Systems, Inc.	JAQ	Class II	2012-06-06
K120712	Fora Comfortscan Ear Thermometer	Taidoc Technology Corporation	FLL	Class II	2012-06-06
K120552	Air Lift/xerostom Artificial Saliva	Biocosmetics Laboratories	LFD	Unclassified	2012-06-06
K120220	Adaptain Soluble Implant Material	Ceremed, Inc.	KHJ	Class II	2012-06-06
K120198	Locator Overdenture Implant System	Zest Anchors LLC	DZE	Class II	2012-06-06
K113785	Adherent Visual Stimulator Goggles	Anschel Technology Inc.	GWE	Class II	2012-06-06
K113363	Angiojet Solent Dista Thrombectomy Set	Medrad, Inc.	QEZ	Class II	2012-06-06
K112627	Millenium Anti-Snoring Device	Millenium Dental Laboratory, Inc.	LQZ	Class II	2012-06-06
K121515	Isolaz 2 Intense Pulsed Light System	Solta Medical, Inc.	ONF	Class II	2012-06-05
K121387	Centricity Pacs-Iw	GE Healthcare	LLZ	Class II	2012-06-05
K120759	Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose Test Strip, Control Solution	I-SENS, Inc.	CGA	Class II	2012-06-05
K120691	Brain Port	Nico Corporation	GZT	Class II	2012-06-05
K120303	Cyberwand Dual Action Ultrasonic Lithotripsy System	Cybersonics, Inc.	FFK	Class II	2012-06-05
K120054	Ultima Neo	Pain Management Technologies	GZJ	Class II	2012-06-05
K113793	Homocysteine Test	Roche	LPS	Class II	2012-06-05
K113703	Bausch + Lomb Nesofilcon a Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	2012-06-05
K113388	Citieffe-Titanium Cannulated Screw	Citieffe Inc.	HWC	Class II	2012-06-05
K112191	Healex Biosponge Wound Dressing	Bionova Medical, Inc.	KGN	Unclassified	2012-06-05
K121413	Crossfix II Memiscal Repair Device	Cayenne Medical Inc.	GAT	Class II	2012-06-04
K121035	Fujinon/fujifilm Ultrasonic Endoscope Eb-530Us	FUJIFILM Healthcare Americas Corporation	EOQ	Class II	2012-06-04
K121008	Trilliant Surgical K-Wires	Trilliant Surgical LLC	HTY	Class II	2012-06-04
K120775	Light for Wrinkles	LED Intellectual Properties LLC	OHS	Class II	2012-06-04
K120689	Synthes 3.5 Mm Va-Lcp Proximal Tibia Plate System	Synthes (USA) Products LLC	HRS	Class II	2012-06-04
K120676	S-250 Proton Beam Radiation Therapy System	Mevion Medical Systems, Inc.	LHN	Class II	2012-06-04
K120471	Mach Brackets Bright Brackets	World Bio Tech Co Ltd	NJM	Class II	2012-06-04
K120435	Browne Aldahol Glutaraldehyde Indicator	STERIS Corporation	JOJ	Class II	2012-06-04
K120370	Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners	Zimmer GmbH	OQG	Class II	2012-06-04
K112766	Snorkel	Fellmar Company	LQZ	Class II	2012-06-04
K120661	The T.a.l.o.n. Intraossous Infusion System by Vidacre	Teleflex Medical	FMI	Class II	2012-06-03
K113597	Mini-Lap Bipolar Electrocautery Devices	Minilap Technologies	GEI	Class II	2012-06-03
K121350	Virtuso System for Ihc (Do-7)	Ventana Medical Systems Inc	NOT	Class II	2012-06-01
K121345	Sr Suite 1.0	Halifax Biomedical Inc.	KPR	Class II	2012-06-01
K121135	Thd Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope	Thd SpA	FER	Class II	2012-06-01
K121073	Powerglide Midline Catheter	C.R. Bard Inc	FOZ	Class II	2012-06-01
K120779	Structur 3	Voco GmbH	EBG	Class II	2012-06-01