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 859 of 3530

510(k) clearances, page 859 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121621	Solocem	Coltene /Whaledent AG	EMA	Class II	2013-01-08
K121261	Asap Muitiscope	asap endoscopic products GmbH	HRX	Class II	2013-01-08
K122643	Vantage Model V5000, V5100, V5000c, V5100c	Midmark Corp	MUH	Class II	2013-01-07
K122288	Brainsway Deep Tms System	Brainsway Ltd.	OBP	Class II	2013-01-07
K121991	Enterococcus Quickfish Bc	Advandx, Inc.	OAH	Class I	2013-01-07
K121752	Avie Total Hb Test System	Mec Dynamics Corp	GKR	Class II	2013-01-07
K121585	Ts Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2013-01-07
K123731	Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray	Glaxosmithkline Consumer Healthcare (Gskch)	LFD	Unclassified	2013-01-04
K123388	K7c Spacer	K7, LLC	ODP	Class II	2013-01-04
K122976	Body Fat Scale Model Sf-371	Shenzhen Belter Health Measurement and Analysis TE	MNW	Class II	2013-01-04
K122854	Arrow Glidethru Peel-Away Sheath/dilator Introducer	Arrow International (Subsidiary of Teleflex Inc.)	DYB	Class II	2013-01-04
K122818	Olympus Maj-172 Instrument Tray for Ltf Videoscope	Olympus Keymed (Medical & Industrial Equipment) LT	KCT	Class II	2013-01-04
K122592	Instinct Java System	Zimmer Spine, Inc.	MNH	Class II	2013-01-04
K113787	Ddu-120 Fully Automatic External Defibrillator and Accessories	Defibtech LLC	MKJ	Class III	2013-01-04
K113516	Therasom-Cast	Family Dental Services, P.C.	LRK	Class II	2013-01-04
K123759	Cg+ Arrow Picc Powered by Arrow Vps Stylet	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	LJS	Class II	2013-01-03
K123712	Retracta Detachable Embolization Coil	Cook Incorporated	KRD	Class II	2013-01-03
K123452	Tracker-17 Microcather, 150 Cm Long and 15.0 Cm Flexible Distal Shaft, Tracker-17 Microcatheter, 150 Cm Long and 7.5 Cm	Stryker Corp.	DQY	Class II	2013-01-03
K123439	Neo Ercp Guidewire	Neometrics, Inc.	OCY	Class II	2013-01-03
K123363	Super Staple(tm) Classic	Metric Medical Devices, Inc.	JDR	Class II	2013-01-03
K123194	Junctional Emergency Treatment Tool Model 30-0088	North American Rescue Products, Inc.	DXC	Class II	2013-01-03
K123102	Sovereign Mini	Aesculap Inc	GCJ	Class II	2013-01-03
K122943	Moorflpi-2 Full-Field Laser Perfusion Imager	Moor Instruments Ltd.	DPT	Class II	2013-01-03
K122483	Pearl Diabetes Management System	Asante Solutions, Inc.	LZG	Class II	2013-01-03
K122237	Biophotas Lifelight	Biophotas, Inc.	ILY	Class II	2013-01-03
K121975	Airvo Humidifier Myairo Humidifier	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2013-01-03
K121108	Dopplex Ability	Huntleigh Healthcare Ltd.	JOM	Class II	2013-01-03
K100695	Colladental Barrier	Collamatrix Co., Inc.	NPL	Class II	2013-01-03
K123877	Quill Pdo Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. dba Angiotech	NEW	Class II	2013-01-02
K122457	Ge Innova/innova Igs/discovery Igs/optima Angiographic, Fluoscopic X-Ray Systems with Cathlab Frontiers Solutions	GE Healthcare	OWB	Class II	2013-01-02
K122273	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lens	Menicon Co. Ltd.	MRC	Class II	2013-01-02
K121296	Interventional Workspot	Philips Medical Systems Nederland B.V.	LLZ	Class II	2013-01-02
K122919	Digital Flat Panel X-Ray Detector11417pca	Rayence Co., Ltd.	MQB	Class II	2013-01-01
K121944	Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent	Diasorin Inc.	CIB	Class II	2013-01-01
K122481	Lipiview Ocular Surface Interferometer	TearScience, Inc.	HKI	Class II	2012-12-31
K122111	Respironics Simplyclear Device	Respironics, Inc.	SDT	Class II	2012-12-31
K123357	Onq Rts	Oncology Systems, Inc.	MUJ	Class II	2012-12-28
K123167	Depuy Pulse Anterior Cervical in-Line Plate System	Medos International SARL	KWQ	Class II	2012-12-28
K122764	Rapid Strand Rx	Medi-Physics, Inc.	KXK	Class II	2012-12-28
K122474	Lansinoh Powered Electric Breast Pump	Lansinoh Laboratories Saglik Gerecleri Tasarim San	HGX	Class II	2012-12-28
K121397	Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit	Sekisui Diagnostics, LLC	KHE	Class II	2012-12-28
K121297	Origin Hip Stem, Femoral Head, Logical Px-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular	Signature Orthopaedics Pty Limited	LPH	Class II	2012-12-28
K121007	Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1	Delta Med SpA	FOZ	Class II	2012-12-28
K123683	Niox Panel for Use with the Niox Mino Airway Inflammation Monitor	Aerocrine AB	MXA	Class II	2012-12-27
K123663	Liquidchek Cardiac Markers Plus Control Lt; Level 1C, Level 2, Level 3, Trilevel Minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2012-12-27
K123591	Flexcath Advance Steerable Sheath (12 French)	Medtronic CryoCath LP	DRA	Class II	2012-12-27
K123526	Clearread +Confirm	Riverain Technologies	LLZ	Class II	2012-12-27
K123419	Eva Select Digital Dental Imaging System	Afp Imaging Corp.	MUH	Class II	2012-12-27
K123091	Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T	Imris, Inc.	MOS	Class II	2012-12-27
K122909	Syngo Single Source Dual Engery	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-12-27