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 864 of 3530

510(k) clearances, page 864 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121391	Inclusive Titanium Abutments for Camlog Screw-Line Implants	Prismatik Dentalcraft, Inc.	NHA	Class II	2012-12-10
K120953	Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System	Tlelflex Medical, Inc.	CAC	Class II	2012-12-10
K120282	Cardnav	Paieon, Inc.	OWB	Class II	2012-12-10
K123462	Ocelot Catheter	Avinger, Inc.	PDU	Class II	2012-12-07
K123446	Tl-300 T-Line Non-Invasive Blood Pressure Monitoring System	United States Gtm Medical Devices, Inc.	DXN	Class II	2012-12-07
K123278	Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self	Kulzer GmbH	KLE	Class II	2012-12-07
K123273	Hoffmann's Cement (Phosphate, Normal)	Temrex Corp.	EMA	Class II	2012-12-07
K123265	Rmgi Low Viscosity	Pulpdent Corporation	EMA	Class II	2012-12-07
K123152	Vitesse 3.0	Varian Medical Systems, Inc.	MUJ	Class II	2012-12-07
K123005	Ddrversa Motion	SWISSRAY Medical, AG	MQB	Class II	2012-12-07
K122953	Omnipod Insulin Managment System	Insulet Corporation	LZG	Class II	2012-12-07
K122861	Xtool	Ouroboros Medical	HRX	Class II	2012-12-07
K122845	Es2 Spinal System Model 48280Xxxx	Howmedica Osteonics Corp	NKB	Class II	2012-12-07
K122760	Affinity Af100 Arterial Filter with Balance Biosurface	Medtronic, Inc.	DTM	Class II	2012-12-07
K122742	Nuvasive Bendini Spinal Rod Bending System	NuVasive Inc	OLO	Class II	2012-12-07
K122733	V2f Anterior Fixation System	Zimmer Spine, Inc.	KWQ	Class II	2012-12-07
K122684	Reverse Medical Microcatheter	Reverse Medical Corporation	DQY	Class II	2012-12-07
K122582	Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C)	Denterprise International, Inc.	EHD	Class II	2012-12-07
K122546	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System	Idev Technologies, Inc.	FGE	Class II	2012-12-07
K122475	Zquiet Pro-Plus	Sleeping Well, LLC	LRK	Class II	2012-12-07
K122330	Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-Sterile	ArjoHuntleigh Polska Sp. zo.o.	JOW	Class II	2012-12-07
K122105	Smi Cardiovascular Patch	Solinas Medical, Inc.	DXZ	Class II	2012-12-07
K121703	Lipokit with Disposable 50Cc Aft Syringe	Medi-Khan USA, Inc.	MUU	Class II	2012-12-07
K121495	Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long	AAP Implantate AG	HRS	Class II	2012-12-07
K120932	Opelaser Pro II and the Opelaser Lite II	The Yoshida Dental Mfg. Co., Ltd.	GEX	Class II	2012-12-07
K120813	Blood Glucose Monitoring System	Andon Medical co., Ltd	NBW	Class II	2012-12-07
K120502	Pc-60Nw Fingertip Oximeter	Shenzhen Creative Industry Co., Ltd	DQA	Class II	2012-12-07
K120454	Safeair Smoke Pencil,	Lna Medical ApS	GEI	Class II	2012-12-07
K122852	Physiostar Nfc	Candulor USA, Inc.	ELM	Class II	2012-12-06
K122787	Comfort Ez	Simple Diagnostics	FMF	Class II	2012-12-06
K122432	Adult Evaqua 2' Dual Heated Breathing Circuits	Fisher & Paykel Healthcare, Inc.	BZE	Class II	2012-12-06
K122322	Piezosurgery Touch	Mectron S.p.A.	DZI	Class II	2012-12-06
K122101	Capillarys Hemoglobin Hba1c Capillarys 2 Flex Piercing Capillarys Hba1c Controls Capillarys Hba1c C	Sebia, Inc.	LCP	Class II	2012-12-06
K122097	Patriot Spacers	Globus Medical, Inc.	MAX	Class II	2012-12-06
K122034	Mrj 3300	Paramed S.r.l.	LNH	Class II	2012-12-06
K121440	Encore Tongue Suspension System Encore Removal-Titration Kit	Siesta Medical, Inc.	ORY	Class II	2012-12-06
K121382	Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]	Westmed Inc	CAH	Class II	2012-12-06
K121341	Fresenius 2008T Hemodialysis Machine with Bibag System	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2012-12-06
K121067	Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator Plate	Exactech, Inc.	PHX	Class II	2012-12-06
K120858	Implant Bar	Prismatik Dentalcraft, Inc.	NHA	Class II	2012-12-06
K120770	Qt Guard Plus Analysis System	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2012-12-06
K112079	Apex Medical Xt Auto CPAP with Compliance Improvement Algorithm 9S-005720	Apex Medical, Inc.	BZD	Class II	2012-12-06
K123622	Acuson	Siemens Medical Solutions USA, Inc.	IYN	Class II	2012-12-05
K123226	Lessray	Saferay Spine, LLC	OWB	Class II	2012-12-05
K123197	Verigene C. Difficile Nucleic Acid Test (Cdf)	Luminex Corporation	OZN	Class II	2012-12-05
K123137	Calypso System	Varian Medical Systems, Inc.	IYE	Class II	2012-12-05
K122759	Omega Laboratories Hair Drug Screening Assay Cardoxy-Thc (Thca)	Omega Laboratories, Inc.	LDJ	Class II	2012-12-05
K122745	Zimmer Persona the Personalized Knee System	Zimmer GmbH	MBH	Class II	2012-12-05
K122645	Mobile Careguide 2100 Oximeter	Reflectance Medical, Inc.	MUD	Class II	2012-12-05
K122630	In:c2 Spinal Fixation System	Spine Smith Partners L.P.	OVE	Class II	2012-12-05