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 855 of 3530

510(k) clearances, page 855 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122159	Dornier Medilas H30 Solvo	Dornier Medtech America, Inc.	GEX	Class II	2013-02-01
K122081	Nuvasive Long Lateral Spinal System	NuVasive Inc	KWQ	Class II	2013-02-01
K121985	Architect Total Bilirubin	Abbott Medical	CIG	Class II	2013-02-01
K121456	Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9Ha Urine Test Strips; Aution Control	Arkray, Inc.	KQO	Class I	2013-02-01
K121418	Planmed Verity	Planmed Oy	JAK	Class II	2013-02-01
K121327	Diolase 10S	Biolase MG LLC	GEX	Class II	2013-02-01
K113504	Deka Smartxide and Delivery Accessories	El.en. Electronic Engineering SpA	GEX	Class II	2013-02-01
K111275	Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software	Abbott Medical	FRN	Class II	2013-02-01
K130013	X4 System	Advanced Brain Monitoring, Inc.	OMC	Class II	2013-01-31
K123775	Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2, Liquichek Spinal Fluid Control Minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2013-01-31
K123764	Durette Ocular Implant	Oculo Plastik, Inc.	HPZ	Class II	2013-01-31
K123691	Magnifuse Bone Graft (Cleared as Grafton II Edbm)	Medtronic Sofamor Danek	MQV	Class II	2013-01-31
K123397	Multilink Automix	Ivoclar Vivadent, Inc.	EBF	Class II	2013-01-31
K123258	The Advance Catheter for Hsg and Sis	Biomerics	LKF	Class II	2013-01-31
K123196	Palindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic Cath	Medtronic, Inc.	MSD	Class II	2013-01-31
K123111	V8 Transluminal Bav Catheter	Intervalve, Inc.	OZT	Class II	2013-01-31
K122696	Powder-Free Nitrile Examination Gloves (Cool Blue)	Medtronic, Inc.	LZA	Class I	2013-01-31
K122396	Powered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Wealth on (Jiangsu) Co., Ltd.	LYZ	Class I	2013-01-31
K113530	Ultrasonic Scaler	Nakanishi Inc.	ELC	Class II	2013-01-31
K113353	Gemini Sterilzation Wrap	MEDLINE INDUSTRIES, LP - Northfield	FRG	Class II	2013-01-31
K112880	Clearpath Ds-120(R) Lens Fluorescence Biomicroscope	Freedom Meditech, Inc.	MYC	Class II	2013-01-31
K123444	Ligasure Impact Curved, Large Jaw, Open Sealer / Divider	Covidien, Formerly Valleylab, A Division of Tyco H	GEI	Class II	2013-01-30
K123369	Ilumien Optis	Lightlab Imaging, Inc.	NQQ	Class II	2013-01-30
K123279	Mini Trek Rx Coronary Dilatation Catheter (Including 1.20 Mm Size), Mini Trek Otw Coronary Dilatation Catheter (Includin	Abbott Vascular	LOX	Class II	2013-01-30
K122928	Digital Flat Panel X-Ray Detector/1417pga	Rayence Co., Ltd.	MQB	Class II	2013-01-30
K122752	Fastect II Ppx Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard	Branan Medical Corp.	JXN	Class II	2013-01-30
K122300	T3 Dental Implant	ZimVie US Corp LLC	DZE	Class II	2013-01-30
K113816	Gc Aadva Abutment- Zirconium-Bo Ac Bh Sv	GC America Inc.	NHA	Class II	2013-01-30
K124048	Imageqube	Intuitive Imaging Informatics, LLC	LLZ	Class II	2013-01-29
K123901	Tractus Tissuemapper Reviewer Application	Tractus Corporation	LLZ	Class II	2013-01-29
K123894	Ge Echopac	GE Vingmed Ultrasound AS	LLZ	Class II	2013-01-29
K123873	Contrast Enhanced Digital Mammography	Hologic, Inc.	MUE	Class II	2013-01-29
K123737	Biograph Mct Family	Siemens Medical Solutions USA, Inc.	KPS	Class II	2013-01-29
K123358	Pacific Plus	Medtronic, Inc.	LIT	Class II	2013-01-29
K123349	A-Scan Plus Connect	Accutome, Inc.	IYO	Class II	2013-01-29
K123269	Procedure Rehearsal Studio	Simbionix, Ltd.	LLZ	Class II	2013-01-29
K123067	Progress Guide Wire Family, Pilot Guide Wire Family	Abbott Vascular	DQX	Class II	2013-01-29
K122890	Inion Cps Orbital Plates	Inion Oy	JEY	Class II	2013-01-29
K122431	Heartspan Steerable Introducer Kit	Merit Medical Systems, Inc.	DYB	Class II	2013-01-29
K121463	Immunocap Allergen K82	Thermo Fisher Scientific Oy	DHB	Class II	2013-01-29
K120603	Varilift -C	Wenzel Spine	ODP	Class II	2013-01-29
K123760	Multiple Name	Assurguard Sdn. Bhd.	LZA	Class I	2013-01-28
K123135	Axera 2 Access System Model Axe200	Arstasis, Inc.	DYB	Class II	2013-01-28
K122156	Orthocon Absorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2013-01-28
K123966	Glucose Meter-Check Solution for Bayer	Bionostics, Inc.	JJX	Class I	2013-01-25
K123956	Power LED 175	Karl Storz Endoscopy-America, Inc.	FCW	Class II	2013-01-25
K123917	Declipsespect Viewer	Surgiceye GmbH	IZD	Class I	2013-01-25
K123632	2.5Mm Turbo Elite 035, 2.3Mm Turbo Elite 035	Spectranetics Corp.	MCW	Class II	2013-01-25
K123560	Vascular Occlusion System (Trufill Pushable Coils), and Trufill Dcs Orbit Detachable Coil Sysem	Cerenovus, Inc.	HCG	Class II	2013-01-25
K123237	Zerona 2.0 Laser	Erchonia Corporation	OLI	Class II	2013-01-25