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 861 of 3530

510(k) clearances, page 861 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123530	Mammography Prior Enhancement (Mpe)	Hologic, Inc.	LLZ	Class II	2012-12-20
K123528	Scenium	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2012-12-20
K123499	Aeropilot	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2012-12-20
K123466	Healthview ECG Manager	Lumedx	DQK	Class II	2012-12-20
K123291	Truebeam	Varian Medical Systems, Inc.	IYE	Class II	2012-12-20
K123255	g.HIamp	G.tec Medical Engineering GmbH	GWL	Class II	2012-12-20
K123168	Q-Plus T+ Ipl Laser System	Quanta System Inc.	GEX	Class II	2012-12-20
K123093	Stabilink Mis Spinal Fixation System	Southern Spine, LLC	KWP	Class II	2012-12-20
K123085	Futuro (Tm) Travel Knee-Highs; Futuro (Tm) Travel Socks; Futuro (Tm) Travel Stockings; Futuro (Tm) Travel Pantyhose	3M Company	DWL	Class II	2012-12-20
K123046	Advia Chemistry Lipoprotein(a) Reagent Advia Chemistry Lipoprotein(a) Calibrator	Siemens Healthcare Diagnostics Inc.	DFC	Class II	2012-12-20
K122991	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2012-12-20
K122975	Gks Prime Flex Cr Total Knee System	Permedica	JWH	Class II	2012-12-20
K122927	Oxicare Fingertip Pulse Oximeter	Delbio Incorporated	DQA	Class II	2012-12-20
K122658	Femcerv Endocervical Sampler Model 3 Sizes: Ref Fcv-013, Ref Fcv-011, Ref Fcv-009	Femasys Inc.	PCF	Class II	2012-12-20
K122575	Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI	Bausch & Lomb Incorporated	LPL	Class II	2012-12-20
K122435	Nova One Blood Glucose Monitor	Nova Biomedical Corporation	LFR	Class II	2012-12-20
K122208	External Fixator System	Christopher D. Endara	NDK	Class II	2012-12-20
K122075	Disposable Gas Sampling Line with and without in-Line Filter	Intersurgical Ltd.	CCK	Class II	2012-12-20
K121998	Hm Surgical Gown, Non Reinforced Hm Surgical Gown, Fabric Reinforced Hm Surgical Gown, Polyerinforced	Changzhou Holymed Products Co., Ltd	FYA	Class II	2012-12-20
K121913	Reprocessed Ultrasound Intracardiac Echo Catheter	Stryker Sustainability Solutions	OWQ	Class II	2012-12-20
K121582	Invendo C25 Colonoscopy System	Invendo Medical Gbmh	FDF	Class II	2012-12-20
K121405	Panoptic	Welch Allyn Inc	HKI	Class II	2012-12-20
K121268	Wandy Dispersvie Electrode	Bio-Med USA, Inc.	ODR	Class II	2012-12-20
K121046	Steroid 21-Hydroxylase Antibody (21-Ohab) Ria Assay Kit	Kronus Market Development Associates, Inc.	PCG	Class II	2012-12-20
K121027	Diamond Calibrator Low, Diamond Calibrator High	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2012-12-20
K120357	Endoscope Reprocessor Oer-Mini	Olympus Medical Systems Corp.	FEB	Class II	2012-12-20
K112910	Ap 72Os Semi-Automated Instrument	Canon Medical Diagnostics USA, Inc.	DHB	Class II	2012-12-20
K111189	Syntec Dental Implant	Syntec Scientific Corp.	DZE	Class II	2012-12-20
K111105	Curasan Osseolive Dental	Curasan AG	LYC	Class II	2012-12-20
K123359	Ovs1 Video System	Olive Medical Corp.	FCW	Class II	2012-12-19
K123184	Finn Chambers Aqua	Smartpractice	KXF	Class I	2012-12-19
K122954	Cincher-2.6 Suture Anchor Model Fg-001	Foundry Newcoxi, Inc.	MBI	Class II	2012-12-19
K122832	Mobicath Transseptal Needle	Great Batch Medical	DRC	Class II	2012-12-19
K122603	Ontex and Other Proprietary Names	Ontex Bvba	HEB	Class II	2012-12-19
K122376	Pmt Truscan Surface Electrode	PMT Corp.	GXY	Class II	2012-12-19
K122321	Basixconpak Analog Inflation Syringe	Merit Medical Ireland, Ltd	MAV	Class II	2012-12-19
K122217	Certus 140 2.45Ghz Ablation System	Neuwave Medical, Inc.	NEY	Class II	2012-12-19
K121803	Intravascular Administration Set	Acta Medical L.L.C.	FPA	Class II	2012-12-19
K121369	Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator	Ibramed Equipamentos Medicos	GZJ	Class II	2012-12-19
K120985	Kimvent Microcuff Subglottic Suctioning	Kimberly-Clark Corporation	BTR	Class II	2012-12-19
K120628	Helio	Motion Composites	IOR	Class I	2012-12-19
K113506	Ind One Step Occult Blood (Fob) Test	Ind Diagnostics, Inc.	KHE	Class II	2012-12-19
K112644	Seaforia Sperm Separation Assistance System	Lotus Bio, Ltd.	MQK	Class II	2012-12-19
DEN090007	Bio-Seal Lung Biopsy Tract System	Angiotech	OMT	Class II	2012-12-19
K123695	Traus Sip10	Saeshin Precision Co., Ltd.	EKY	Class I	2012-12-18
K123568	Vertex Reconstruction System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2012-12-18
K123564	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	IYN	Class II	2012-12-18
K123561	Elvarex/elvarex Soft/elvarex Soft Seamless	BSN Medical	DWL	Class II	2012-12-18
K123398	Dr. Scholl's Compression Socks	Renfro LLC	DWL	Class II	2012-12-18
K123318	Idrive Ultra Powered Handle and Endo Gia Adapter	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2012-12-18