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 884 of 3530

510(k) clearances, page 884 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121839	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular Inc.	DQY	Class II	2012-08-08
K121172	Reform Pedicle Screw System	Spinal USA	MNI	Class II	2012-08-08
K121168	Aptus 18Fr Helifx Guide-22 Deflectable Length	Aptus Endosystems, Inc.	OTD	Class II	2012-08-08
K121102	Osteosymbionics Peek Cranial Implant	Osteosymbionics, LLC	GXN	Class II	2012-08-08
K120585	Convey Guiding Catheter	Pendracare International B.V.	DQY	Class II	2012-08-08
K113820	Neutrophase Antimicrobial Wound Cleanser	Novabay Pharmaceuticals, Inc	FRO	Unclassified	2012-08-08
K113776	Flashpak	Symmetry Medical	FRG	Class II	2012-08-08
K113507	Kent Camera	Kent Imaging Inc	MUD	Class II	2012-08-08
K112787	Kerator	KJ Meditech Co., Ltd.	NHA	Class II	2012-08-08
K112162	Conical Connection Implants	MIS Implants Technologies Ltd.	DZE	Class II	2012-08-08
K122141	Ids-Isys Igf-I Calibration Verifiers	Immunodiagnostic Systems Ltd.	JJX	Class I	2012-08-07
K121393	Smith & Nephew, Inc. Total Knee System Instrumentation	Smith & Nephew, Inc.	MBH	Class II	2012-08-07
K121059	Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim	Zimmer Medizinsystems Corp	IMG	Class II	2012-08-07
K120994	BD BACTEC Plus PRIME Aerobic/F Culture Vials	Becton Dickinson & Co	MDB	Class I	2012-08-07
K113795	Suction Lipolasty Accessories	Norman M. Black Iii	QPB	Class II	2012-08-07
K113783	Vitek 2 Ast- Gram Postive Penicillin for Streptococcus Pneumoniae	bioMerieux, Inc.	LON	Class II	2012-08-07
K111953	Nautilus Spinal System	Life Spine	NKB	Class II	2012-08-07
K122006	G-Scan Brio	Esaote S.p.A.	LNH	Class II	2012-08-06
K121698	Nupro Sensodyne Prophylaxis Paste with Novamin	Dentsply International, Inc.	EJR	Class I	2012-08-06
K121158	Reprocessed Electrophysiology Diagnostic Catheters	Sterilmed Inc	NLH	Class II	2012-08-06
K120536	Heart Sync Pediatric Physio AED Pad	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	MKJ	Class III	2012-08-06
K113437	Ace Hemoglobin Alc(hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	LCP	Class II	2012-08-06
K112532	Et II Bio-Sa Fixture System	Hiossen, Inc.	DZE	Class II	2012-08-06
K122118	Hakim Programmable and Precision Valve Shunt System	Cerenovus, Inc.	JXG	Class II	2012-08-03
K121996	Be Plus Ltm Amplifier Gwi Amplifier	EB Neuro S.p.A.	GWL	Class II	2012-08-03
K121990	Picc Convenience Kit	Boston Scientific Corporation	LJS	Class II	2012-08-03
K121789	Shangring	Wuhu Snna Medical Treatment Appliance Technology C	HFX	Class II	2012-08-03
K121526	Power-Free Nitrile Patient Examination Gloves	Shandong Junchi Medical Products Co., Ltd.	LZA	Class I	2012-08-03
K121337	Uroplasty Rigid Endoscpic Needles	Uroplasty, LLC	FBK	Class II	2012-08-03
K121289	Ltm-Labaroscopic Surgical Mesh	LifeCell Corp	OXK	Class II	2012-08-03
K121192	Nitrile Examination Gloves (White, Blue and Black)	Tekmedic (M) Sdn Bhd	LZA	Class I	2012-08-03
K121048	Ultraflex Tracheobronchial Stent System- Sterile Uncovered	Boston Scientific Corporation	JCT	Class II	2012-08-03
K120961	Trevo Retriever	Concentric Medical, Inc.	NRY	Class II	2012-08-03
K120898	Keyport System, Includes: Keyport Silicone Sealing Insert 8850Xxx Keyport Trucar 8850Xx Keyport Trocar 8850Xx Sealing Ca	Richard Wolf Medical Instruments Corp.	OTJ	Class II	2012-08-03
K120451	8Mp Color Lcd Monitor, Rediforce Rx840	Eizo Nanao Corporation	LLZ	Class II	2012-08-03
K120423	Bionime Rightest Blood Glucose Monitoring System, Model Gm650	Bionime Corporation	NBW	Class II	2012-08-03
K113673	Mysafety Syringe	Medicalchain Internartional Corporation	FMF	Class II	2012-08-03
K113536	Masterka 40 Masterka 35 Masterka 30	Fci SAS (France Chirurgie Instrumentation)	OKS	Unclassified	2012-08-03
K113077	Bioland G-423 Glood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2012-08-03
K112692	Identify	Humediq GmbH	IYE	Class II	2012-08-03
K122121	Pulsioflex Monitoring System with Picco Module	Pulsion Medical Systems SE	DXG	Class II	2012-08-02
K122073	Eli 280 Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2012-08-02
K121940	Lanx Spinal Fixation System	Lanx, Inc.	NKB	Class II	2012-08-02
K121867	Sonotouch Series Diagnostic Ultrasound Systems	Chison Medical Imaging Co., Ltd.	IYN	Class II	2012-08-02
K121525	Perifuse Catheter	Abbott Medical	CAZ	Class II	2012-08-02
K121410	Dragon Lw	Sedecal S.A.	IZL	Class II	2012-08-02
K121267	Bt-200V Vascular Doppler	Bistos co., Ltd.	HGM	Class II	2012-08-02
K121184	Sensus	Neurometrix, Inc.	GZJ	Class II	2012-08-02
K121157	Powder-Free Vivyl Patient Examination Gloves, Clear (Non-Colored)	Shijazhuang Jiuyuan Plastic Co., Ltd.	LYZ	Class I	2012-08-02
K120917	Headway Duo Microcatheter	Terumo Cardiovascular Systems Corporation	DQO	Class II	2012-08-02