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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 610 of 3529

510(k) clearances, page 610 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163211	MAGNETOM Sempra with syngo MR E11S	Siemens Medical Solutions USA, Inc.	LNH	Class II	2017-01-27
K163042	chromID Strepto B agar	bioMerieux, Inc.	PQZ	Class I	2017-01-27
K162909	CSX-30 Flat Panel Detector	Canon Inc. -Medical Equipment Group	MQB	Class II	2017-01-27
K162842	ASAHI PTCA Guide Wire ASAHI SUOH 03	Asahi Intecc Co., Ltd.	DQX	Class II	2017-01-27
K162631	VERIFY STEAM Integrating Indicator - Short	STERIS Corporation	JOJ	Class II	2017-01-27
K162427	Vado Bi-Directional Steerable Sheath	Kalila Medical, Inc.	DYB	Class II	2017-01-27
K162407	L300 Go System	Bioness, Inc.	GZI	Class II	2017-01-27
K162285	EBM iDO Viewer 1.2.1	Ebm Technologies Incorporated	LLZ	Class II	2017-01-27
K162088	Ecomed Disposable Angiographic Syringes	Ecomed Solutions, LLC	DXT	Class II	2017-01-27
K161967	FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm	Callisyn Biomedical, Inc.	KRA	Class II	2017-01-27
K161767	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boeblingen GmbH	DXJ	Class II	2017-01-27
K161688	Advanced Gynecological Applicator	Nucletron BV	JAQ	Class II	2017-01-27
K161236	Universa Firm Ureteral Stents and Stent Sets	Cook Incorporated	FAD	Class II	2017-01-27
K163715	Allura Xper R9	Philips Medical Systems Nederland B.V.	OWB	Class II	2017-01-26
K163693	IntraClude Intra-Aortic Occlusion Device	Edwards Lifesciences LLC	DXC	Class II	2017-01-26
K163660	Pantera LEO	BIOTRONIK AG	LOX	Class II	2017-01-26
K163574	Multi Modality Viewer	Canon Medical Informatics, Inc.	LLZ	Class II	2017-01-26
K163368	Fitbone Taa	Wittenstein Intens GmbH	HSB	Class II	2017-01-26
K163281	FastStroke	Gef Medical Systems Scs	JAK	Class II	2017-01-26
K163179	Onli Intermittent Catheter	Hollister Incorporated	GBM	Class II	2017-01-26
K163044	ORTHOLOC® 3Di Ankle Fracture Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2017-01-26
K162882	KARL STORZ ICG Imaging System	Karl Storz Endoscopy-America, Inc.	OWN	Class II	2017-01-26
K162790	V.A.C.ULTA Negative Pressure Wound Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2017-01-26
K162587	Roccia® Acif	Silony Medical GmbH	ODP	Class II	2017-01-26
K161303	dynaMX™ Compression Plate	Mx Orthopedics, Corp.	HRS	Class II	2017-01-26
K161219	Zmaxx T Series	Maxx Digm, Inc.	EIH	Class II	2017-01-26
K163258	CrossFT Knotless Suture Anchor with Disposable Driver	ConMed Corporation	MBI	Class II	2017-01-25
K162988	PreludeSYNC Radial Compression Device	Merit Medical Systems, Inc.	DXC	Class II	2017-01-25
K162786	PASS LP Spinal System	Medicrea International	NKB	Class II	2017-01-25
K162226	Reliant Multistage Dilatation Balloon Catheter	Micro-Tech (Nanjing) Co., Ltd.	FGE	Class II	2017-01-25
K161273	StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis	Zimmer GmbH	MBB	Class II	2017-01-25
K160976	Altus Spine Interbody Fusion System	Altus Partners	MAX	Class II	2017-01-25
K170074	nvc	Nvision Biomedical Technologies, Inc	ODP	Class II	2017-01-24
K163705	EzRay Air W	Vatech Co., Ltd.	EHD	Class II	2017-01-24
K163014	AOS Small Bone Nailing System	Advanced Orthopaedic Solutions, Inc. (Aos)	HSB	Class II	2017-01-24
K163006	VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)	bioMerieux, Inc.	LON	Class II	2017-01-24
K162924	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)	Hartalega Sdb. Bhd.	LZA	Class I	2017-01-24
K162851	eLyx-PRO	Intelligent Sensory Concept SA	GEX	Class II	2017-01-24
K162802	Barrx Anorectal RFA Wand	Medtronic, Inc.	GEI	Class II	2017-01-24
K161686	F&P InfoSmart	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2017-01-24
K161466	ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System	Orthofix SRL	HSB	Class II	2017-01-24
K163107	Lifestyles Zero Lubricated Latex Male Condom	Ansell Healthcare Products LLC	HIS	Class II	2017-01-23
K162962	OrthAlign Plus System	OrthAlign, Inc.	OLO	Class II	2017-01-23
K162618	CONCORD Plus Radiopaque Bone Cement	Globus Medical, Inc.	NDN	Class II	2017-01-23
K162606	Elecsys TSH assay, cobas e 801 Immunoassay analyzer	Roche Diagnostics GmbH	JLW	Class II	2017-01-23
K161823	Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs	WRP Asia Pacific Sdn Bhd	KGO	Class I	2017-01-23
K161275	EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip	Research Instruments Ltd	MQH	Class II	2017-01-23
K161231	Facilis™ Spinal System	Baui Biotech Co., Ltd.	NKB	Class II	2017-01-23
K160591	D.O.R.C. Disposable Cryo Probe	Dutch Ophthalmic Research Center International BV	HRN	Class II	2017-01-23
K163620	Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves	Medtronic, Inc.	JOW	Class II	2017-01-19