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 827 of 3530

510(k) clearances, page 827 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130136	Disposable and Reusable Concentric Needle Electrodes,disposable and Reusable Subdermal Needle Electrodes,	Technomed Europe	GXZ	Class II	2013-07-19
K130079	Multi-Parameter Mobile Careguide 3100 Oximeter	Reflectance Medical, Inc.	MUD	Class II	2013-07-19
K130068	Dismounted Medical & Supplemental Oxygen System (Dmos)	Essex Industries, Inc. D/B/A Essex Cryogenics of M	BYJ	Class II	2013-07-19
K124055	T1040 Aka Aurawave	Endurance Therapeutics	NUH	Class II	2013-07-19
K122988	Klockner Dental Implant Abutments	Soadco, S.L.	NHA	Class II	2013-07-19
K120510	Transcend	Syneron Medical, Ltd.	GEI	Class II	2013-07-19
K131905	Solid Gel Pad	Bluemtech	MUI	Class II	2013-07-18
K131805	Inpulse Laser	Incisive, LLC	GEX	Class II	2013-07-18
K131776	Aldolase Controls Level 2, and Aldolase Control Level 3	Randox Laboratories, Limited	JJX	Class I	2013-07-18
K131688	Neoclose Hasson, Neoclose Universal	Neosurgical, Ltd.	GCJ	Class II	2013-07-18
K131467	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2013-07-18
K131327	Bioarterial Plus Arterial Blood Flow Enhancement System	Bio Compression Systems, Inc.	JOW	Class II	2013-07-18
K131179	Centrimag Primary Console (2Nd Generation); Mag Monitor	Abbott Medical	DWA	Class II	2013-07-18
K131137	21.3 Inch Monochrome Digital Mammography Lcd Monitor Ms55i2 (Ml21055, Md211g5)	JVCKENWOOD Corporation	LLZ	Class II	2013-07-18
K131046	Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)	Venous Health Systems, Inc.	JOW	Class II	2013-07-18
K130399	Certus 140 Certusurggt Surgical Tool	Neuwave Medical, Inc.	NEY	Class II	2013-07-18
K130224	Ict	Imris, Inc.	JAK	Class II	2013-07-18
K130088	Port View, Digital X-Ray Sensor System	Genoray Co., Ltd.	MUH	Class II	2013-07-18
K123332	Naomi-CT	Lk Consulting Group	OAS	Class II	2013-07-18
K131853	Mentor Memoryshape Resterilizable Gel Sizer	Mentor Worldwide, LLC	MRD	Unclassified	2013-07-17
K131544	Cobas C Bilirubin Total Gen.3	Roche Diagnostics GmbH	CIG	Class II	2013-07-17
K131077	Life Spine Plateau Spacer System	Life Spine	MAX	Class II	2013-07-17
K130987	Valutrode Neurostimlation Electrodes	Axelgaard Mfg. Co., Ltd.	GXY	Class II	2013-07-17
K130906	Endoflip Catheter	Crospon, Ltd.	FFX	Class II	2013-07-17
K130766	Roadrunner Uniglide Hydrophilic Wire Guide	Cook Inc.	DQX	Class II	2013-07-17
K130083	Demecaprone (Poliglecaprone 25) Synthetic Monofilament (Pgcl) Absorbable Suture	Demetech Corp.	GAM	Class II	2013-07-17
K123787	Greencross Surgical Mask	Jingzhou Haixin Green Cross Medical Products Co.,L	FXX	Class II	2013-07-17
K123753	Imdx Vanr for Abbott M2000	Intelligent Medical Devices, Inc.	NIJ	Class II	2013-07-17
K123660	25-Oh Vitamin D Elisa	Euroimmun US Inc.	MRG	Class II	2013-07-17
K113126	Acrylic Herbst Appliance	Gergens Orthodontic Lab	LRK	Class II	2013-07-17
K131504	Universal Opaque	Shofu Dental Corp.	EBF	Class II	2013-07-16
K131434	Vs3 Stereoscopic High Definition Vision System	Visionsense, Ltd.	GWG	Class II	2013-07-16
K131428	Radvision	Acoustic Medsystems, Inc.	MUJ	Class II	2013-07-16
K131358	Bd Pen Needle	Becton Dickinson & Co	FMI	Class II	2013-07-16
K131233	Hermes Medical Imaging Suite V5.3	Hermes Medical Solutions AB	KPS	Class II	2013-07-16
K131120	Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2013-07-16
K130536	Export Advance Aspiration Catheter	Medtronic, Inc.	QEZ	Class II	2013-07-16
K122402	Lpp (Low Profile Port)	PFM Medical GmbH	LJT	Class II	2013-07-16
K131763	Truscope Series Patient Monitor	Guangdong Biolight Meditech Co., Ltd	MHX	Class II	2013-07-15
K131382	Expression Mr200 MRI Patient Monitoring System, Expression Ip5 Information Portal	Invivo Corporation	MWI	Class II	2013-07-15
K131185	Ana Screen Elisa (Igg)	Euroimmun US Inc.	LJM	Class II	2013-07-15
K131040	Extavipro Sterican 30G	B.Braun Melsungen AG	FMI	Class II	2013-07-15
K130953	Neotis; Neotis 50	Sbm Sciences for Bio Materials	MQV	Class II	2013-07-15
K130657	Linkdr 2.0 Diabetes Management Software	All Medicus Co., Ltd.	NBW	Class II	2013-07-15
K130585	Pch-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source X-Ray System	Vatech Co., Ltd.	MUH	Class II	2013-07-15
K130360	Constant Care Lilah Home Health Monitoring System - Multi-User Version	Constant Care, LLC	DRG	Class II	2013-07-15
K130253	Tq-Prep Workstation, Prepplus 2 Workstation	Siemens Healthcare Diagnostics Inc.	PER	Class I	2013-07-15
K130186	Dentek Easy Brush with Fluoride	Den Tek Oral Care, Inc.	EFW	Class I	2013-07-15
K130051	611 Ankle Fusion Nail	Tornier S.A.S.	HSB	Class II	2013-07-15
K123364	25Oh Vitamin D Total Elisa Test	DiaSource ImmunoAssays, SA	MRG	Class II	2013-07-15