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 902 of 3530

510(k) clearances, page 902 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113355	Posey Bed	J. T. Posey Co.	OYS	Class I	2012-05-02
K113088	Hummingbird Subdural H900ds (Drainage and Icp), Hummingbird Subdural- H800s (Icp Only)	Innerspace, Inc.	GWM	Class II	2012-05-02
K112924	Rs Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name	Riverstone Resources Sdn Bhd	LZA	Class I	2012-05-02
K112288	Jiajian TENS	Wuxi Jiajian Medical Instrument Co., Ltd	GZJ	Class II	2012-05-02
K111008	Microware Bone Plates and Bone Screw	Microware Precision Co., Ltd.	HRS	Class II	2012-05-02
K121044	Illumigene Group B Streptococcus Carrot Broth Claim	Meridian Bioscience Inc	NJR	Class I	2012-05-01
K120748	Speedup Software Option	Esaote S.p.A.	LNH	Class II	2012-05-01
K113833	Vital Signs Monitor	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2012-05-01
K113384	External Fixator St.a R 90 F4	Citieffe Inc.	KTT	Class II	2012-05-01
K113145	Echelon Oval MRI System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2012-05-01
K112986	Lateral Fusion Device	Integra Spine (Integra Lifesciences)	MAX	Class II	2012-05-01
K112801	Ayers Rock Cervical Cage	Qualgenix	ODP	Class II	2012-05-01
K112684	Mont Blanc Pedicle Screw Systems	Qualgenix	NKB	Class II	2012-05-01
K112593	Styker Consolidated Operating Room Equipment (Core) System	Stryker Corp.	ERL	Class II	2012-05-01
K111929	Psychemedics Cannabinoids Eia	Psychemedics Corp.	LDJ	Class II	2012-05-01
K111928	Psychemedics Phencyclidine Eia	Psychemedics Corp.	LCM	Unclassified	2012-05-01
K111927	Psychemedics Methamphetamine Eia	Psychemedics Corp.	LAF	Class II	2012-05-01
K111926	Psychemedics Opiates Eia	Psychemedics Corp.	DJG	Class II	2012-05-01
K111925	Psychemedics Cocaine Eia	Psychemedics Corp.	JXO	Class II	2012-05-01
K110212	Inratio2 Pi/nr Monitoring System; Inratio Pt/inr Test Strip	Alere San Diego, Inc (Formally Biosite Incorporate	GJS	Class II	2012-05-01
K120492	K2 Medical Vascular Clamps	K2 Medical GmbH & Co. KG	DXC	Class II	2012-04-30
K120215	Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile	Intuitive Surgical, Inc.	NAY	Class II	2012-04-30
K113687	Equinox Relieve	O-Two Medical Technologies, Inc.	BZR	Class II	2012-04-30
K112909	Ocd04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion	Bausch & Lomb Incorporated	LPN	Class II	2012-04-30
K112148	Powered Muscle Stimulator	Valmed SRL	IPF	Class II	2012-04-30
K110530	Abx Pentra Creatinine 120 Cp; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control	Horiba Abx SAS	CGX	Class II	2012-04-30
DEN120013	Portrait Analyzer	Great Basin Scientific, Inc.	OMN	Class I	2012-04-30
DEN110016	Percutaneous Surgical Set with 5Mm or 10Mm Attachments	Ethicon Endo-Surgery Inc	OXT	Class II	2012-04-30
K121106	Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression Gauntlet	Surgical Appliance Industries, Inc.	DWL	Class II	2012-04-27
K120962	Pathassist Light Fiber	Entellus Medical, Inc.	LRC	Class I	2012-04-27
K120935	Securacath	Interrad Medical Inc	OKC	Class II	2012-04-27
K120764	Epiflo(r)	Neogenix, LLC	KPJ	Class II	2012-04-27
K120746	Disposable Powder Free Vinyl Exam Gloves	Canopus Medical Supply Co., Ltd.	LYZ	Class I	2012-04-27
K120741	Voluson S6, Voluson S8	GE Healthcare	IYN	Class II	2012-04-27
K120341	Plastic Needle with Mandrin 2.0 Diameter Length 113Mm	Varian Medical Systems, Inc.	JAQ	Class II	2012-04-27
K120108	Aptus Proximal Humerus System	Medartis AG	HRS	Class II	2012-04-27
K120043	Csm Internal-R Implant System	CSM Implant	DZE	Class II	2012-04-27
K113848	R3 Xlpe Liners	Smith & Nephew, Inc.	MBL	Class II	2012-04-27
K113837	Powder Free Vinyl Patient Examination Gloves	Hebei Changsheng Plastic Products Co.,Ltd.	LYZ	Class I	2012-04-27
K113707	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating	Medtronic, Inc.	KGO	Class I	2012-04-27
K113616	Accudxa2	Lone Oak Medical Technologies, LLC	KGI	Class II	2012-04-27
K113599	Surgicase Connect	Materialise N.V.	LLZ	Class II	2012-04-27
K113286	Encore 14 Software Release for the Ge Lunar Dxa Bone Densitometers	GE Medical Systems Lunar	KGI	Class II	2012-04-27
K113221	Namsa Biological Indicator Spore Strips	North American Science Assoc., Inc.	FRC	Class II	2012-04-27
K113119	Endogator Advantage Irrigation Pump	Byrne Medical, Inc.	OCX	Class II	2012-04-27
K112535	Genesis Reusable Rigid Container System	Medtronic, Inc.	KCT	Class II	2012-04-27
K112314	Nephros Olpur H2h Hemodiafiltration (Hdf) Module and Olpur Md 220 Hemodiafilter	Nephros Inc	KDI	Class II	2012-04-27
K111895	Echotip(r) Ultra Fiducial Needle	Wilson-Cook Medical Inc./Cook Endoscopy	NEU	Class II	2012-04-27
K111250	Dry Mouth Mouthwash	Dr. Fresh, Inc.	LFD	Unclassified	2012-04-27
K110629	Resmart CPAP, Resmart Auto-CPAP and Resmart Humidifier	3B Products, LLC	BZD	Class II	2012-04-27