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 1000 of 3531

510(k) clearances, page 1000 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102476	Teleradpro	Vidar Systems Corp.	LMA	Class II	2010-10-07
K102269	Elecsys Ige Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-10-07
K102248	Excella II Spinal System Model Ec2-00	Innovasis, Inc	NKB	Class II	2010-10-07
K102133	Giraffe2	Sybron Dental Specialties, Inc.	MVL	Unclassified	2010-10-07
K101939	Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System	Merete GmbH	HSB	Class II	2010-10-07
K101280	Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe	Midwest Reprocessing Center, LLC	NLF	Class II	2010-10-07
K101166	4D-View 9.1 (4D View Pc Software) Model: H48651sz	GE Healthcare	LLZ	Class II	2010-10-07
K100077	Nellcor Compatible Reusable Spo2 Soft-Finger Sensor, Model T100a-090103	Solaris Medical Technology, Inc.	DQA	Class II	2010-10-07
K092973	Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle	Bionen S.A.S.	IKT	Class II	2010-10-07
K092601	Immulisa Anca Screen Elisa	Immco Diagnostics, Inc.	MOB	Class II	2010-10-07
K092600	Immulisa Pr3 Antibody Elisa	Immco Diagnostics, Inc.	MOB	Class II	2010-10-07
K092599	Immulisa Mpo Antibody Elisa	Immco Diagnostics, Inc.	MOB	Class II	2010-10-07
K102277	Interfuse T Invertebral Body Fusion Device	Vertebral Technologies, Inc.	MAX	Class II	2010-10-06
K102099	Powder Free Vinyl Patient Examination Gloves	Hong di Plastic Products Co., Ltd.	LYZ	Class I	2010-10-06
K102092	Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model Rp Ceries	Prestige Ameritech	MSH	Class II	2010-10-06
K102089	Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2010-10-06
K102006	Cryomega	Stc Consulting, LLC	GEH	Class II	2010-10-06
K101760	Elegant Blue, White, Pink Powder Free, Nitrile Examination Gloves	Profit Point Manufacturing Sdn Bhd	LZA	Class I	2010-10-06
K100933	Consensus Cs2 Plus Acetabular Insert	Consensus Orthopedics, Inc.	LPH	Class II	2010-10-06
K100123	Acumed Wrist Arthrodesis Plate System	Acumed LLC	HRS	Class II	2010-10-06
K093683	Orthopantomograph Op300	Palodex Group Oy	MUH	Class II	2010-10-06
K093438	Paradigm Interspinous Fusion Plate	Paradigm Spine GmbH	KWP	Class II	2010-10-06
K092398	Hsv Straw	Cryo Bio System	MQK	Class II	2010-10-06
K102596	Atrium Graduated Wall Flixene Ax-Bifem Graft	Atrium Medical Corporation	DSY	Class II	2010-10-05
K102256	Ge Logiq I/e & Vivid E Compact Diagnostic Ultrasound	GE Medical Systems China Co., Ltd.	IYN	Class II	2010-10-05
K102150	Syngo Dynamics, Version 9.0	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2010-10-05
K102094	Powder Free Vinyl Patient Examination Gloves	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2010-10-05
K102069	Journey Unicondylar Tibial Baseplates	Smith & Nephew, Inc.	HSX	Class II	2010-10-05
K101874	Ge Logiq P6/p6 Pro	GE Healthcare	IYN	Class II	2010-10-05
K101856	Elecsys Cea Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-10-05
K101813	Imrx System V1 and Imrisnv/imriscardio	Imris, Inc.	LNH	Class II	2010-10-05
K101809	Fujirebio Diagnostics Tumor Marker Control Model 108-20	Fujirebio Diagnostics, Inc.	JJY	Class I	2010-10-05
K101768	Mie Scintron Gamma Camera Systems	Miegmbh	KPS	Class II	2010-10-05
K101657	Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40	Boston Scientific Corporation	KGE	Class II	2010-10-05
K101586	Xtra Autotransfusion System	Corcym Inc.	CAC	Class II	2010-10-05
K101365	Elecsys Ca 19-9 Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-10-05
K101324	Ge Echopac Model Bt10	GE Vingmed Ultrasound AS	LLZ	Class II	2010-10-05
K100991	Imc Surgical Drape	Intl. Medsurg Connection, Inc.	KKX	Class II	2010-10-05
K100903	Anti-Hav	Roche Professional Diagnostics	LOL	Class II	2010-10-05
K100356	Tds Precision Dental Bar	Pou YU Biotechnology Co., Ltd.	NHA	Class II	2010-10-05
K093893	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System	Idev Technologies, Inc.	FGE	Class II	2010-10-05
K093816	Digital Radiography System, Models Galaxy 900 and 1600	Medien International Co, Ltd.	KPR	Class II	2010-10-05
K102687	Mirada Rt	Mirada Medical Limited	LLZ	Class II	2010-10-04
K102477	No!no! Skin	Radiancy (Israel), Ltd.	OLP	Class II	2010-10-04
K102431	Powder-Free Vinyl Patient Examination Gloves	Tangshan Fuqiang Glove Co., Ltd.	LYZ	Class I	2010-10-04
K102362	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Jiangsu Huayuan Gloves Co., Ltd.	LYZ	Class I	2010-10-04
K102361	Zip'r4/ Zip'r4 Xtra Scooter	Global Fabtech Wheelchair (Shanghai) Co., Ltd.	INI	Class II	2010-10-04
K102358	Zip'r3/ Zip'r3 Xtra Scooter	Global Fabtech Wheelchair (Shanghai) Co., Ltd.	INI	Class II	2010-10-04
K102355	Zip'r Mantis Powered Wheelchair	Global Fabtech Wheelchair (Shanghai) Co., Ltd.	ITI	Class II	2010-10-04
K102160	Stretch Vinyl Examination Glove Powder Free	Shandong Blue Sail Innovation Co Ltd	LYZ	Class I	2010-10-04