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 2026-11-05, 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 1304 of 3531

510(k) clearances, page 1304 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052232	Vascular Solutions Pronto V3 Extraction Catheter	Vascular Solutions LLC	QEZ	Class II	2005-09-28
K052131	Expedium Spine System 5.5Mm Commerically Pure Titanium Spinal Rods	DePuy Spine, Inc.	KWP	Class II	2005-09-28
K052009	Conmed System Model 2450 Electrosurgical Generator	ConMed Corporation	GEI	Class II	2005-09-28
K051951	Cerament Bone Void Filler	Bonesupport Inc	MQV	Class II	2005-09-28
K051940	Cm 3910 Rotating Double Scheimpflug Camera	Sis Ltd., Surgical Instrument Systems	MXK	Class II	2005-09-28
K051861	The Savion Industries Medi-Cruiser Model Ms777	Savion Industries, Ltd.	INK	Class II	2005-09-28
K051469	Carevent Atv+ and Carevent MRI	O-Two Medical Technologies, Inc.	BTL	Class II	2005-09-28
K052579	Portal Gravity System	Portal, Inc.	LNH	Class II	2005-09-27
K052542	Accolade Rps Hip Stem	Stryker Orthopaedics	LZO	Class II	2005-09-27
K052489	Actiheart	Respironics, Inc.	GWK	Class II	2005-09-27
K052434	Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera	GE Healthcare	KPS	Class II	2005-09-27
K052422	The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)	Flow X-Ray Corp.	EAP	Class II	2005-09-27
K052309	Digital Hand Dynamometer, Model Sh5003; Digital Pinch Gauge, Model Sh5006	Saehan Corporation	LBB	Class II	2005-09-27
K052235	Lcr	3M Company	EMA	Class II	2005-09-27
K052172	Hhf1 Magnetic Resonance Imaging System	FUJIFILM Healthcare Americas Corporation	LNH	Class II	2005-09-27
K051895	Ge Datex-Ohmeda Engstrom Carestation	GE Healthcare	CBK	Class II	2005-09-27
K051887	Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)	Mission Systems Davenport Inc.	CAW	Class II	2005-09-27
K051865	Terumo Surguard 2 Safety Needle or Similar	Terumo Medical Corp.	MEG	Class II	2005-09-27
K051726	Arthrex Tenodesis Family	Arthrex GmbH	HWC	Class II	2005-09-27
K051667	Ez-Ject	Indolor, Ltd.	KZH	Class II	2005-09-27
K051404	B-Care Powder Free Latex Examination Gloves	B-Care Industries Co., Ltd.	LYY	Class I	2005-09-27
K050327	E-Poly (Vitamin E) Acetabular Liners	Zimmer GmbH	LPH	Class II	2005-09-27
K052559	Wu's Powered Wheelchair, Mambo 2	Wu's Tech Co., Ltd.	ITI	Class II	2005-09-26
K052521	Nissin Series Mechanical Wheelchair	Nissin Medical Industries Co., Ltd.	IOR	Class I	2005-09-26
K052418	Axxess Butterfly Anchor	Abbott Medical	GZB	Class II	2005-09-26
K052373	Quill Nonabsorbable Polypropylene Barbed Suture	Quill Medical, Inc.	GAW	Class II	2005-09-26
K051856	Trans1 Facet Screws	Trans1 Incorporated	MRW	Unclassified	2005-09-26
K051772	Asahi Tornus Support Catheter	Asahi Intecc Co., Ltd.	DQY	Class II	2005-09-26
K051741	Accolade Hfx Femoral Stem	Stryker Orthopaedics	LZO	Class II	2005-09-26
K051730	Matrix Holter System, Model M12	Global Instrumentation Corp.	MLO	Class II	2005-09-26
K051537	Hilt Family Laser: Hilt I, Hilt II, Hilt III	Cynosure, LLC	ILY	Class II	2005-09-26
K051369	Syryker Sorano Wheelchair	Stryker Canada	IOR	Class I	2005-09-26
K052554	Modification to: Ivent 201 Portable Ventilator	Versamed Medical Systems, Inc.	CBK	Class II	2005-09-23
K052402	Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2005-09-23
K052376	Modification to: Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2005-09-23
K052245	Accent and Exceed Series Orthodontic Ceramic Brackets	Lar Mfg., LLC	NJM	Class II	2005-09-23
K052123	Synthes Pangea System	Synthes (USA) Products LLC	KWP	Class II	2005-09-23
K052056	Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum	Thermo Electron Oy	JJY	Class I	2005-09-23
K051978	Trabecular Metal Vertebral Body Replacement	Implex Corp.	MQP	Class II	2005-09-23
K051859	Sistema De Implante Nacional (S.i.n.); Dental Implant System	Sin Sistema de Implante Nacional Ltda	DZE	Class II	2005-09-23
K051835	Npac Multi-Use Ear Thermometer, Models Tp 700,Tp 702	Norm Pacific Automation Corp.	FLL	Class II	2005-09-23
K051762	Saf-T-Syringe/saf-T-Needle	Safety Medical International, Incorporated	MEG	Class II	2005-09-23
K051629	Bleas Esiriuc Anaesthsia System, Models 3000, 2000	Blease USA, Inc.	BSZ	Class II	2005-09-23
K051459	Sysmex Model Xe-2100Dc Automated Hematology Analyzer	Sysmex America, Inc.	GKZ	Class II	2005-09-23
K051355	Vanishpoint i.v. Catheter	Retractable Technologies, Inc.	FOZ	Class II	2005-09-23
K051222	Av-S Anaesthesia Ventilator	Penlon, Ltd.	CBK	Class II	2005-09-23
K051048	Surgisis Staple Line Reinforcement II	Cook Biotech, Inc.	FTM	Class II	2005-09-23
K050637	Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral Heads	Ortho Development Corp.	JDI	Class II	2005-09-23
K050518	Reprocessed Phacoemuisification Tips	Alliance Medical Corp.	NKX	Class II	2005-09-23
K050448	Chromopep Pc, Chromopep at, Models 2.5 and 5	Horiba Abx	GGP	Class II	2005-09-23