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 904 of 3530

510(k) clearances, page 904 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113240	3.7 Mp Color Lcd Monitor, Radiforce Mx270w	Eizo Nanao Corporation	LLZ	Class II	2012-04-20
K112992	Earlogic Oae Tester	Earlogic Corporation	EWO	Class II	2012-04-20
K112795	Paltop Dental Implant System	Paltop Advanced Dental Solutions Ltd	DZE	Class II	2012-04-20
K112666	Saline Wound Wash	Nanoplas, Inc.	FRO	Unclassified	2012-04-20
K111425	Olympus Ltf-S190-10, Olumpus Otv-S190, Olympus Clv-S190	Olympus Medical Systems Corp.	HET	Class II	2012-04-20
K121019	Optima Nm/ct 640	GE Healthcare	KPS	Class II	2012-04-19
K121010	M7/m7t Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2012-04-19
K120971	Atlas Pta Balloon Dilatation Catheter	Bard Peripheral Vascular Inc	LIT	Class II	2012-04-19
K120880	Orbit	National Biomedical, LLC dba Qrs Diagnostic	BZG	Class II	2012-04-19
K120863	Wholey Guide Wire System	Medtronic, Inc.	DQX	Class II	2012-04-19
K120859	Pre-Loaded Gold Visicoil Ck Marker	Radiomed Corporation	KXK	Class II	2012-04-19
K120818	Otis-C Plus	Science for Biomaterials	HRS	Class II	2012-04-19
K120722	Rival Pta Dilatation Catheter	Bard Peripheral Vascular Inc	LIT	Class II	2012-04-19
K120718	Instapacs/instarispacs	Meddiff Technologies Pvt., Ltd.	LLZ	Class II	2012-04-19
K120699	Dc-T6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2012-04-19
K120407	2Mp Monochrome Lcd Monitor, Radiforce Gx240	Eizo Nanao Corporation	LLZ	Class II	2012-04-19
K120316	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2012-04-19
K120255	Philips Microdose	Philips Digital Mammography Sweden AB	MUE	Class II	2012-04-19
K120234	Ezono 3000	Life-Tech, Inc.	IYN	Class II	2012-04-19
K120201	Ge Vivid E9 Diagnostic Ultrasound Imaging System	GE Vingmed Ultrasound AS	IYO	Class II	2012-04-19
K120196	Olea Sphere	Olea Medical	LLZ	Class II	2012-04-19
K120182	Neomed Gastrointestinal Tube and Accessories	Halyard Health	KNT	Class II	2012-04-19
K120076	Resolutionmd Web	Calgary Scientific, Inc.	LLZ	Class II	2012-04-19
K120063	Venus Lumbar Intervertebral Body Fusion Cage System	L&K Biomed Co.,Ltd.	MAX	Class II	2012-04-19
K113831	Primus Hearing Instrument Test Unit	Auditdata A/S	ETW	Class II	2012-04-19
K113789	Modular Proximally Fluted Hip Stem	Smith & Nephew, Inc.	MEH	Class II	2012-04-19
K113494	Noblestitch El Noblestitch Mr Noblestitch Ta	Nobles Medical Technologies II, Inc.	GAW	Class II	2012-04-19
K112843	Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2012-04-19
K112536	Sonicision Sterilization Tray	Medtronic, Inc.	KCT	Class II	2012-04-19
K112286	Novac 11	New Radiant Technology S.p.A.	IYE	Class II	2012-04-19
K111872	Virtuoso System for Ihc P53 (Do-7)	Ventana Medical Systems Inc	NQN	Class II	2012-04-19
K111464	Palm-Pro Powder Free Nitrile Examination Gloves	Dipped Products (Thailand) Ltd	LZA	Class I	2012-04-19
K120881	Mantaray Guidewires	Boston Scientific Corporation	DQX	Class II	2012-04-18
K120531	Versafitcup Cc Trio-Additional Liners	Medacta International SA	LZO	Class II	2012-04-18
K113586	Synergeyes Sih (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens	Synergeyes, Inc.	HQD	Class II	2012-04-18
K113488	Jazzy Elite 6	Pride Mobility Product Corporration	ITI	Class II	2012-04-18
K113398	Nexus Tko-6, Luer-Activated Device	Nexus Medical, LLC	FPA	Class II	2012-04-18
K113332	On Call Chosen Lancing Device	Acon Laboratories, Inc.	FMK	Class II	2012-04-18
K112816	Zhenjiang Asure Mechanical Wheelchair	Zhenjiang Assure Medical Equipment Co Ltd	IOR	Class I	2012-04-18
K112696	Twin Peaks Lumbar Cage	Qualgenix	MAX	Class II	2012-04-18
K112440	Ab Dental Devices Implants and Accessories	A.B. Dental Devices Ltd	DZE	Class II	2012-04-18
K102428	Wunder Test	Hien Helen Nguyen	LDJ	Class II	2012-04-18
K121001	Copression Systems (Models Cmp-001 and Cmp-002)	Novitas Medical, LLC	JOW	Class II	2012-04-17
K120850	Target Detachable Coil	Stryker Corp.	HCG	Class II	2012-04-17
K120816	Inzone Detachment System	Stryker Corp.	KRD	Class II	2012-04-17
K120591	Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2	DIAMOND DIAGNOSTICS Inc	JIT	Class II	2012-04-17
K120367	3Mensio Workstation	PIE Medical Imaging B.V.	LLZ	Class II	2012-04-17
K120165	Intraosseous Fixation System	TORNIER Inc.	HTY	Class II	2012-04-17
K120034	Radiographic X-Ray System	Orich Medical Equipment (Tianjin) Co., Ltd.	KPR	Class II	2012-04-17
K120028	Aquamax (Etafilcon a) Disposable Soft Contact Lenses	Pegavision Corporation	LPL	Class II	2012-04-17