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 2026-10-26, 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 767 of 3530

510(k) clearances, page 767 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133288	Caspian Oct Spinal System	K2M, Inc	KWP	Class II	2014-07-01
K132903	Dre Ventura	Dre Medical, Inc.	BSZ	Class II	2014-07-01
K132036	Hypervisor Central Monitoring System (Including Telemetry Monitoring System, Tms-6016)	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	MSX	Class II	2014-07-01
K141447	Precice Trauma Nail System	Ellipse Technologies, Inc.	HSB	Class II	2014-06-30
K141395	Delta Tt Acetabular System	Lima Corporate S.p.A.	LPH	Class II	2014-06-30
K141374	Bicarbonate Calibrator	Beckman Coulter Ireland Inc	JIT	Class II	2014-06-30
K141045	Mbd Plate System	Mbd Medical, LLC	HRS	Class II	2014-06-30
K140833	Itotal Posterior Stabilized (Ps) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2014-06-30
K140751	Mirocam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2014-06-30
K140674	Exactech Tapered Wedge Femoral Stem	Exactech, Inc.	LZO	Class II	2014-06-30
K140243	Shuntong	Shuntong Glove Co., Ltd.	LYZ	Class I	2014-06-30
K133575	Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.l.i.s. Pedicle Screw Fixation System	Spinevision Inc.	MNH	Class II	2014-06-30
K133189	Dual Shot Alpha 7	Nemoto Kyorindo Co., Ltd.	DXT	Class II	2014-06-30
K132551	Zf 720	Umbel Corporation	FSY	Class II	2014-06-30
K132491	Mueller Hinton Agar	Edge Biologicals, Inc.	JTZ	Class II	2014-06-30
K132354	Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile	Advanced Health Products, Lot 60 & 61	LZA	Class I	2014-06-30
K124021	Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System	ARKRAY Factory, Inc.	CGA	Class II	2014-06-30
K141578	Devon Cirona 6200 Dvt	Devon Medical, Inc.	JOW	Class II	2014-06-27
K141428	Mdmc-12133	Barco N.V.	PGY	Class II	2014-06-27
K141413	Crc Pc with Smart Chamber	Mirion Technologies (Capintec), Inc.	KPT	Class II	2014-06-27
K141179	A&d Medical Ub-543 Digital Blood Pressure Monitor	A&D Company, Ltd.	DXN	Class II	2014-06-27
K140823	Permanent Beacon Transponder/soft Tissue Beacon Transponder	Varian Medical Systems, Inc.	IYE	Class II	2014-06-27
K140819	Surgical Navigation Advanced Platform	Surgical Theater Inc	LLZ	Class II	2014-06-27
K140788	P-Stim	Biegler GmbH	BWK	Unclassified	2014-06-27
K140701	Novohip Bipolar Head/novohip Vitamin E Liner/ Bone Screws/ Hole Plug	Novosource, LLC	OQG	Class II	2014-06-27
K140650	Hivox Electric Stimulator OTC TENS	Hivox Biotek Inc.	NUH	Class II	2014-06-27
K140542	Navage Nasal Irrigator, Navage Nose Cleaner	Rhinosystems, Inc.	KMA	Class I	2014-06-27
K140289	Instru-Safe Instrument Protection System	Summit Medical, LLC	KCT	Class II	2014-06-27
K140132	Biodentine	Septodont	KIF	Class II	2014-06-27
K133901	Pari-Path Surgical Navigation System	Paritic, Inc.	JAK	Class II	2014-06-27
K133843	Saber Percutaneous Transluminal Angioplasty Dilatation Catheter	Cordis US Corp.	LIT	Class II	2014-06-27
K133632	Perican Ultra	B.Braun Medical, Inc.	BSP	Class II	2014-06-27
K133260	Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System	Tianjin Empecs Medical Device Co., Ltd.	NBW	Class II	2014-06-27
K132195	Euroimmun Anti-Pla2r Elisa (Igg)	Euroimmun US Inc.	PGV	Class II	2014-06-27
K130755	Hicut Highspeed Instrument	Adeor Medical AG	HBE	Class II	2014-06-27
K141454	Sony Digital Printer Up-D898md/sony Hybrid Printer Up-X898md	Sony Electronics Inc.	LMC	Class II	2014-06-26
K141397	Sure-Lok C Extended Tab Pedicle Screw System	Precision Spine, Inc.	MNI	Class II	2014-06-26
K141376	Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws	Nexxt Spine LLC	MNH	Class II	2014-06-26
K141346	Sony Hybird Graphic Up-971Ad, Sony Hybird Graphic Printer Up-991Ad	Sony Electronics Inc.	LMC	Class II	2014-06-26
K141002	Vs3 Stereoscopic High Definition Vision System	Visionsense, Ltd.	HRX	Class II	2014-06-26
K140803	Luneray;catheter 6F 50Cm, Needle 37Mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm	Nucletron BV	JAQ	Class II	2014-06-26
K140659	Coroent Thoracolumbar Implants	Nu Vasive, Incorporated	MAX	Class II	2014-06-26
K140588	Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens	Stryker Corp.	FXY	Class II	2014-06-26
K140435	Medley Gold	American Dental Sleep Medicine, Ip, LLC	LRK	Class II	2014-06-26
K140053	Kangli Pedicle Screw Spinal System	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	MNH	Class II	2014-06-26
K133961	Suresigns Vs3, Suresigns Vs4	Philips North America LLC	DSJ	Class II	2014-06-26
K133579	Multifilament Stainless Steel Sutures with Crimps	Pontis Orthopaedics, LLC	MBI	Class II	2014-06-26
K133465	Consure Stool Management System	Consure Medical Pvt, Ltd.	KNT	Class II	2014-06-26
K133194	Diamond Rattlesnake System	Eminent Spine	KWQ	Class II	2014-06-26
DEN130034	Rewalk	Lifeward, Inc.	PHL	Class II	2014-06-26