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 782 of 3530

510(k) clearances, page 782 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130456	Wunder Pregnancy Test	James Nguyen	JHI	Class II	2014-04-08
K130171	Flight 60 Ventilator	Flight Medical Innovations Ltd.	CBK	Class II	2014-04-08
K140372	Fragment Plate System	Skeletal Dynamics, Inc	HRS	Class II	2014-04-07
K140069	Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated Pcs 3.0	Merete GmbH	HRS	Class II	2014-04-07
K140007	Abacus Tm Spacer System	Spine Wave Inc	MAX	Class II	2014-04-07
K133844	Speed Triad	Biomedical Ent., Inc.	JDR	Class II	2014-04-07
K133743	Baxano Surgical Mis Spinal System	Baxano Surgical, Inc.	NKB	Class II	2014-04-07
K133235	Threaded Peek K-Wire	Mtp Solutions, LLC	MBI	Class II	2014-04-07
K133155	Hydrophilic Coated Guidewire	Lake Region Medical	DQX	Class II	2014-04-07
K132902	Syngo Dual Energy Software Package	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-04-07
K140702	8Mp Color Lcd Monitor, Radiforce Rx850	Eizo Corporation	PGY	Class II	2014-04-04
K140315	US Endoscopy Distal Attachment Cap	United States Endoscopy Group, Inc.	OCX	Class II	2014-04-04
K140018	Tsp Hip Fracture Plating System	Zimmer GmbH	JDO	Class II	2014-04-04
K133936	Artus C. Difficile Qs-Rgq Mdx Kit	Qiagen	OZN	Class II	2014-04-04
K133910	Nordicbrainex	NordicNeuroLab AS	LLZ	Class II	2014-04-04
K133873	Triball Incentive Spirometer	Besmed Health Business Corporation	BWF	Class II	2014-04-04
K133777	Tornier Insite(tm) Ft Peek Knotless Suture Anchor	TORNIER Inc.	MBI	Class II	2014-04-04
K133669	Medinaut Kyphoplasty System	Imedicom Co., Ltd.	NDN	Class II	2014-04-04
K133572	Aria Radiation Therapy Management	Varian Medical Systems, Inc.	IYE	Class II	2014-04-04
K133470	Bard Ritecath Intermittent Catheter	C.R. Bard Inc	EZD	Class II	2014-04-04
K133377	Nobelprocera Angulated Screw Channel Abutment Replace	Nobel Biocare AB	NHA	Class II	2014-04-04
K132911	I.b.s Snap-Off Screw / Solafix Snap-Off Screw	In2Bones SAS	HWC	Class II	2014-04-04
K132381	Clearmri Helios-Rg8 Coil Accessory Kit	Clearmri Solutions, Inc.	LNH	Class II	2014-04-04
K130959	Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior Gel	Bioplax Limited	OLR	Unclassified	2014-04-04
K130878	Cloudekg	Makromed, Inc.	DXH	Class II	2014-04-04
K130014	A1c Gear System	Sakae Corporation	LCP	Class II	2014-04-04
K140461	Mach LED 2Mc	Dr. Mach GmbH & Co. KG	FSY	Class II	2014-04-03
K140460	Mach LED 2Sc	Dr. Mach GmbH & Co. KG	FSY	Class II	2014-04-03
K140402	Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male Adapter, Medsource IV Extension Set	Medsource International, LLC	LHI	Class II	2014-04-03
K140376	Variax 2 System	Stryker Trauma GmbH	HRS	Class II	2014-04-03
K140131	Sub-Q Subcutaneous Tissue Infusion Set	Emed Technologies Corporation	FPA	Class II	2014-04-03
K140072	Cryotop(r) Sc	Kitazato Biopharma Co., Ltd.	MQK	Class II	2014-04-03
K140043	Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head	Microport Orthopedics Inc.	LZO	Class II	2014-04-03
K140003	Coroent Small Interbody System	NuVasive Inc	ODP	Class II	2014-04-03
K133914	Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle	Medcom GmbH	LHN	Class II	2014-04-03
K133834	Depuy Global Unite Shoulder System	Depuy (Ireland)	KWS	Class II	2014-04-03
K133614	Aleutian Ibf System	K2M, Inc	MAX	Class II	2014-04-03
K133139	Vizion Ultra	Viztek, LLC	MQB	Class II	2014-04-03
K132914	Acuity Pro Lead Delivery System	Boston Scientific Corporation	DQY	Class II	2014-04-03
K132488	Zoll Code Writer	ZOLL Medical Corporation	DXJ	Class II	2014-04-03
K132447	Vitalconnect Platform by Vital Connect Inc.	VitalConnect, Inc.	DRG	Class II	2014-04-03
K132105	Perclot Topical	Artivion, Inc.	QSY	Unclassified	2014-04-03
K131541	Flexible Cooagen Nerve Cuff	Collagen Matrix, Inc	JXI	Class II	2014-04-03
K131202	Medicalyte(r) Bicarbonate Powder (36.83X), Medicalyte(r) Bicarbonate Powder (45X), Medicalyte(r) Bicarbonate Powder (35X	Dialysis Medical Solutions, LLC	KPO	Class II	2014-04-03
K130757	Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set	Spencer Fillmore	JAQ	Class II	2014-04-03
DEN130016	Xstat	Revmedx Inc	PGZ	Class II	2014-04-03
K140257	Signature Planner, Signature Guides	Materialise N.V.	MBH	Class II	2014-04-02
K133933	Injection Gold Probe Bipolar Electrohemostasis Catheter	Boston Scientific Corporation	KNS	Class II	2014-04-02
K132483	Innesis Peek Cervical Cage	BK Meditech Co., Ltd.	ODP	Class II	2014-04-02
K132021	Ahp 300, Emergency Portable Ventilator	Allied Medical LLC	BTL	Class II	2014-04-02