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 915 of 3530

510(k) clearances, page 915 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112831	Pleurx Pleural Catheter Systems	Care Fusion	DWM	Class II	2012-02-16
K112680	Evis Exera III Video System	Olympus Medical Systems Corp.	FDF	Class II	2012-02-16
K112330	Kowa Vx-20	Kowa Co., Ltd.	HKI	Class II	2012-02-16
K112271	3B Willow	3B Products, LLC	BZD	Class II	2012-02-16
K111874	Freestyle Insulinx Blood Glucose Monitoring Systems	Abbott Medical	LFR	Class II	2012-02-16
K111860	Bd Max Gbs Assay, Bd Max Instrument	Becton Dickinson & Co	NJR	Class I	2012-02-16
K111689	Stlase	Dental Photonics, Inc.	GEX	Class II	2012-02-16
K111521	Waves	Waters Medical Systems LLC	KDN	Class II	2012-02-16
K111473	Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator	ZOLL Medical Corporation	CBK	Class II	2012-02-16
K111448	Icon (Tm) Modular Pedicle Screw System	Orthofix SRL	NKB	Class II	2012-02-16
K110825	Philips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunction Electrodes	Philips North America LLC	MKJ	Class III	2012-02-16
K110404	Eaum Total Knee System	Corentec Co., Ltd.	JWH	Class II	2012-02-16
K120140	Focus Spinal System	L&K Biomed Co.,Ltd.	NKB	Class II	2012-02-15
K113724	Electropulse-Cosmetic	Pain Relief Technologies	NFO	Class II	2012-02-15
K113723	Tephaflex Mesh	Tepha, Inc.	OOD	Class II	2012-02-15
K113721	Tephaflex Light Mesh	Tepha, Inc.	OOD	Class II	2012-02-15
K113409	S2 Femoral A/r Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail	Howmedica Osteonics Corp	HSB	Class II	2012-02-15
K113378	Conformis Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2012-02-15
K110748	Olympus Instrument Tray	Olympus Winter & Ibe GmbH	KCT	Class II	2012-02-15
K110278	Cordless Prosthodontic Screwdriver with Torque Calibration System, Model Isd900	Nakanishi Inc.	EKX	Class I	2012-02-15
DEN120001	Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase	Phadia AB	OYL	Class II	2012-02-15
K120144	Vital Signs Monitor	Edan Instruments, Inc.	DXN	Class II	2012-02-14
K120137	Victory Guidewire (32 Models)	Brivant, Ltd.	DQX	Class II	2012-02-14
K120132	Suresigns Vs3 Vital Signs Monitor, Suresigns Vs4 Vital Signs Monitor	Philips North America LLC	DXN	Class II	2012-02-14
K113722	Disposable Powder Free Vinyl Exam Glove, Blue Color	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-02-14
K113710	Disposable Powder Free Vinyl Exam Glove, Yellow Color	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-02-14
K113634	Injekt Cysto Flexible Injection Needle	Cook Ireland Ltd.	FBK	Class II	2012-02-14
K113551	Esophageal Tts Stent	Taewoong Medical Co., Ltd.	ESW	Class II	2012-02-14
K113496	Virture Male Sling System with Alexis Wound Retractor Convenience Kit	MEDLINE INDUSTRIES, LP - Northfield	OTM	Class II	2012-02-14
K113403	Ge Discovery Igs Angiographic,fluoroscopic X-Ray System	GE Medical Systems SCS	OWB	Class II	2012-02-14
K113390	Laser Indirect Ophthalmoscope 500(Lio-500)	Meridian AG	GEX	Class II	2012-02-14
K111938	Ids-Isys Igfbp-3 Control Set, Ids-Isys Human Growth Hormone (Hgh) Calibration Verifiers, and Ids-Isys Igfbp-3 Cal...	Immunodiagnostic Systems Ltd.	JJX	Class I	2012-02-14
K111758	Cadens (Tm) Colon	Dog Microsystems, Inc.	LLZ	Class II	2012-02-14
K111018	Polyfuse - Neurobone	Atpac Medical, LLC	MQV	Class II	2012-02-14
K113406	Aquasil Ultra Smart Wetting Impression Material	Dentsply International, Inc.	ELW	Class II	2012-02-13
K112595	Coflex-F	Paradigm Spine GmbH	KWP	Class II	2012-02-13
K111405	Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,	Hangzhou Bever Medical Devices Co., Ltd.	GBM	Class II	2012-02-13
K120268	Amid Stapler	Safestich Medical, LLC	GDW	Class II	2012-02-10
K120131	Regius Sigma2	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2012-02-10
K120122	Sense Msk S 8Ch 1.5T	Invivo Corporation	MOS	Class II	2012-02-10
K113697	Eigr Surgical Illumination System	Invuity, Inc.	FST	Class II	2012-02-10
K113612	Aida V1.5 Diagnostic Ultrasound System Gm-72P00a	Panasonic Healthcare Co., Ltd.	IYN	Class II	2012-02-10
K113542	Salter Labs Bubble Humidifier (High Flow)	Salter Labs, Arvin Facility	BTT	Class II	2012-02-10
K113362	Spinevu Endoscopic Spine System (Sess)	Spine View, Inc.	HRX	Class II	2012-02-10
K113305	Vitek 2 Streptococcus Trimethoprim/sulfamethoxazole	bioMerieux, Inc.	LON	Class II	2012-02-10
K113259	Notouch Breastscan	UE Lifesciences Inc.	LHQ	Class I	2012-02-10
K112994	Cre Ditatation Ballon	Boston Scientific Corporation	FGE	Class II	2012-02-10
K112888	Meso Wound Matrix	DSM Biomedical, Inc.	KGN	Unclassified	2012-02-10
K112042	Kingyield Wrist Blood Pressure Monitor	Shenzhen Kingyield Technology Co., Ltd	DXN	Class II	2012-02-10
K112016	L-Ser Ko Lamp	YA-Man Ltd.	ILY	Class II	2012-02-10