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 1454 of 3531

510(k) clearances, page 1454 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031229	Telzuit Cardiac Monitoring System	Telzuit Technologies, Inc.	DXH	Class II	2003-07-09
K031199	Enteralite Infinity Enteral Feeding Pump	Zevex Intl., Inc.	LZH	Class II	2003-07-09
K030638	Duramax .035 Biliary Stent System, Models Dml0718-80, Dml0718-135, Dml0818-80, Dml0818-135, Dml0918-80, Dml0918-135, Dml	Avantec Vascular Corp.	FGE	Class II	2003-07-09
K031929	5Mp Tft Lcd Monitor System If2105a by Wide Corporation	Wide Corporation	LLZ	Class II	2003-07-08
K031690	Cynosure Yag Family Laser (Photogenica Yag and Acclaim)	Cynosure, LLC	GEX	Class II	2003-07-08
K031555	Synthes (USA) Compartmental Pressure Monitoring System	Synthes (USA) Products LLC	LXC	Unclassified	2003-07-08
K031453	Terumo Surguard 2 Safety Needle	Terumo Medical Corp.	FMI	Class II	2003-07-08
K031258	Cynosure Photolight Pl	Cynosure, LLC	GEX	Class II	2003-07-08
K031163	Sez Safety Syringe	Sez Corporation	MEG	Class II	2003-07-08
K031118	Intraos 70	Blue X Imaging SRL	EHD	Class II	2003-07-08
K023836	The Suad Device	Strong Dental, Inc.	LRK	Class II	2003-07-08
K022967	Suile Wound Dressing	Hedonist Biochemical Technologies Co., Ltd.	FRO	Unclassified	2003-07-08
K022558	Ngt	Medical Innovative Products	KNT	Class II	2003-07-08
DEN030004	West Nile Virus Igm Capture Elisa	Panbio Limited	NOP	Class II	2003-07-08
K031905	Digital Clinical Thermometer, Models Act2130, Act 2230, Act 2330, Act 3136, and Act 3030	Actherm, Inc.	FLL	Class II	2003-07-07
K031777	Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2003-07-07
K031383	Model 780	Hudson Respiratory Care, Inc.	BTT	Class II	2003-07-07
K031208	Reaads Igm Anti-B2gpi Test Kit, Model 038-001	Corgenix, Inc.	MSV	Class II	2003-07-07
K031055	Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2003-07-07
K030470	Nxstage System One	NxStage Medical Inc	FII	Class II	2003-07-07
K030271	Ventlab Bacterial Filter, Model Bf100	Salter Labs	CAH	Class II	2003-07-07
K030076	Professional Blood Sample Retrieval System	Biomed Personal Metabolic and Nutritional Testing	JKA	Class II	2003-07-07
K024204	Fotona Fidelis Plus Nd:yag Laser System	Fotona D.D.	GEX	Class II	2003-07-07
K020332	Respiratory Humidifier, Model Mr850	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2003-07-07
K031843	Modification to Evencare Blood Glucose Monitoring System	MEDLINE INDUSTRIES, LP - Northfield	NBW	Class II	2003-07-03
K031755	Accu-Chek Compact Test Strip	Roche Diagnostics GmbH	LFR	Class II	2003-07-03
K031623	Modification to Coalescent Surgical U-Clip and Accessories	Coalescent Surgical	FZP	Class II	2003-07-03
K031484	Stand Out	Sybron Dental Specialties, Inc.	ELW	Class II	2003-07-03
K031422	Philips Page Writer Trim Series Cardiograph Including I, II, III, Models 860286, 860287, 860288, 860289, 860290, 860291	Philips North America LLC	DPS	Class II	2003-07-03
K031193	Soft (Hydrophilic) Contact Lens Care Solution	Alcon, Inc.	LPN	Class II	2003-07-03
K031133	Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis	Surgrx, Inc.	GEI	Class II	2003-07-03
K031070	Carbon Fiber Bridge, Model 28757	Nobel Biocare AB	EBI	Class II	2003-07-03
K030919	Siss, Inc. (D.b.a.medisiss) Reprocessd Electrosurgical Instruments and Accessories	Medisiss	NLR	Class II	2003-07-03
K030329	Fastpack Free T4 Immunoassay	Qualigen Inc	CEC	Class II	2003-07-03
K024337	General Semen Analysis (Gsa) Kit	Bioshaf, Ltd.	POV	Class II	2003-07-03
K024303	Edwards Lifesciences Lifestent Nt18 Self-Expanding Biliary Stent and Delivery System	Edwards Lifesciences LLC	FGE	Class II	2003-07-03
K031927	Ge Delta Software Option for MRI	GE Healthcare	LNH	Class II	2003-07-02
K031827	Ultraflex Venous Cannula, Model 970Xx and Cb970xx	Medtronic Perfusion Systems	DWF	Class II	2003-07-02
K031807	Synthes Low Profile Neuro System - 3 Mm Screws	Synthes (USA) Products LLC	DZL	Class II	2003-07-02
K031790	Slide-on Endosheath System for Sensory Testing	Cogentix Medical, Inc.	EOB	Class II	2003-07-02
K031747	Spi Dental Implant Abutments	Thommen Medical AG	NHA	Class II	2003-07-02
K031719	Esthetic Zirconia Abutment	Nobel Biocare AB	NHA	Class II	2003-07-02
K031718	Lifevalve Central Venous Cathter	Boston Scientific Corporation	LJS	Class II	2003-07-02
K031688	Rapido Cut-a-Way Rotating Hemostasis Valve	Boston Scientific Corporation	DTL	Class II	2003-07-02
K031478	Microheater	Belmont Medical Technologies	BSB	Class II	2003-07-02
K031476	Fill-in	Sybron Dental Specialties, Inc.	EBG	Class II	2003-07-02
K031444	Optibond Fl	Kerr Dental Materials Center	KLE	Class II	2003-07-02
K031372	Personal Digital Workstation (Pdw); Film Digitizing Camera and Digital Workstation	Maxxvision, LLC	LLZ	Class II	2003-07-02
K031276	Synthes Anterior Cervical Locking Plate (Aclp) System	Synthes (USA) Products LLC	KWQ	Class II	2003-07-02
K030899	C-Reactive Protein (Crp)	Abbott Medical	DCN	Class II	2003-07-02