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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1001 of 3531

510(k) clearances, page 1001 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102096	Powder Free Nitrile Examination Gloves, Blue	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2010-10-04
K101999	Kaiyang Steel Wheelchair	Guangdong Kaiyang Medical Technology Co., Ltd.	IOR	Class I	2010-10-04
K101998	Kaiyang Aluminum Wheelchair	Guangdong Kaiyang Medical Technology Co., Ltd.	IOR	Class I	2010-10-04
K101871	Trusignal Spo2 Fingertip Sensor	GE Healthcare Finland Oy	DQA	Class II	2010-10-04
K101828	Powder Free Latex Examination Gloves (18 Ml), Blue Tested for Use with Chemotherapy Drugs	Gx Corporation Sdn Bhd	LYY	Class I	2010-10-04
K101598	Emm Surgical Drape Sms W/pe Sides Model 13-005 (with Minor Dimensional Variations for Alternate Configurations)	Exact Medical Manufacturing, Inc.	KKX	Class II	2010-10-04
K101084	Caspian Spinal System	K2M, Inc	KWP	Class II	2010-10-04
K100213	Lumanosity Celebrity, Model 204	Lumanosity, Inc.	ILY	Class II	2010-10-04
K092723	Akro Vu Videoscopic Carpal Tunnel Release (Vctr) System	Skeletal Dynamics, Inc	HRX	Class II	2010-10-04
K102684	Xelis Dental	Infinitt Co., Ltd.	LLZ	Class II	2010-10-01
K102216	Xio Rtp System	Elekta Limited	MUJ	Class II	2010-10-01
K102104	Ge Vivid P3 Diagnostic Ultrasound Imaging System	Wipro GE Healthcare Private Ltd.	IYN	Class II	2010-10-01
K101992	3D Scanner, Model 1230	Sun Nuclear Corporation	IYE	Class II	2010-10-01
K101880	Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant	ZimVie US Corp LLC	DZE	Class II	2010-10-01
K101849	Bicon Dental Implant System 3.0Mm Bicon Dental Implant	Bicon, LLC	DZE	Class II	2010-10-01
K101831	Enterix Insurefit Fob Controls, Model 16800	Bionostics, Inc.	OSL	Class II	2010-10-01
K101622	Zimmer Natural Nail System Retrograde Femoral Nails	Zimmer GmbH	HSB	Class II	2010-10-01
K101606	Micromed Pd-8K Insulation Defect Detector	Mcgan Technology, LLC	HFG	Class II	2010-10-01
K101528	3M Comply Lead Free Process Indicators for Steam	3M Company	JOJ	Class II	2010-10-01
K101347	Magnetom Aera; Magnetom Skyra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2010-10-01
K101223	Spectralis Hra+oct, Spectralis Fa_oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis Fa	Heidelberg Engineering GmbH	OBO	Class II	2010-10-01
K101148	Warm Air Model 135 Hyperthermia System and Blankets	Gentherm Medical, LLC	DWJ	Class II	2010-10-01
K100042	Difusion Technologies Xiphos Interbody Fusion System	Difusion Technologies	MAX	Class II	2010-10-01
K093837	Athena Multi-Lyte Treponema Pallidum Igg Plus Test System	Zeus Scientific, Inc. (Zeus)	LIP	Class II	2010-10-01
K091989	Perfadex and Perfadex with Tham	Xvivo Perfusion, Inc.	KDN	Class II	2010-10-01
K102495	M3290b Intellivue Information Center Software, Release A.0	Philips North America LLC	MHX	Class II	2010-09-30
K102492	P200maaf	Optos PLC.	MYC	Class II	2010-09-30
K102468	Zoll Propaq Md	ZOLL Medical Corporation	LDD	Class II	2010-09-30
K102438	Primalok Facet Fixation System	Osteomed	MRW	Unclassified	2010-09-30
K102373	Calypso System with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	LHN	Class II	2010-09-30
K102156	Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws	TORNIER Inc.	HRS	Class II	2010-09-30
K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System	Spine Smith Partners L.P.	OVD	Class II	2010-09-30
K101772	Tsrh(r) Spinal System	Medtronic Sofamor Danek	NKB	Class II	2010-09-30
K101537	Aim 200, Major Surgical Light	Burton Medical Products Corp.	FSY	Class II	2010-09-30
K101337	A6 Portable Ultrasonic Diagnostic System	Sonoscape Company Limited	IYO	Class II	2010-09-30
K101311	Ep Navigator R3	Philips North America LLC	LLZ	Class II	2010-09-30
K101200	Pillcam Express Video Capsules Delivery Device	Given Imaging Ltd.	NEZ	Class II	2010-09-30
K093107	Immulite 2000 3Gallergy Specific Ige Assay Kit	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2010-09-30
K102265	Ldr Spine USA C-Plate, Tl Anterior Cervical Plate System	Ldr Spine USA	KWQ	Class II	2010-09-29
K101958	Amsino i.v. Administration and Extension Sets	Amsino International, Inc.	FPA	Class II	2010-09-29
K101869	Proglass Cements (One, Two Two Lc, Nine, Plus, Silver)	Silmet Ltd.	EMA	Class II	2010-09-29
K101825	Cryoballoon Ablation System	PENTAX of America, Inc.	GEH	Class II	2010-09-29
K101611	Relay Power Wheelchair	Dalton Instrument Corp.	ITI	Class II	2010-09-29
K101524	C2000 Powered Wheelchair	Otto Bock Healthcare LP	ITI	Class II	2010-09-29
K100391	Depuy Universal Gription Tf Cones	Depuy Orthopaedics Inc.	JWH	Class II	2010-09-29
K100114	Fat Concentration System	Zimmer GmbH	MUU	Class II	2010-09-29
K093834	Crit-Line Anemia Management Software	Hema Metrics, LLC	MSQ	Class I	2010-09-29
K092977	Eberle Shaver System Accessories	Efs Eberle Feinwerktechnische Systeme	HRX	Class II	2010-09-29
K102716	Modified Alma Lasers Family of Soprano Xl Multi-Application Platmforms	Alma Lasers Ltd.	GEX	Class II	2010-09-28
K102036	Doctor Surgery Diode Lasers Family	Lambda SpA	GEX	Class II	2010-09-28