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 1457 of 3531

510(k) clearances, page 1457 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031065	Syringex Safety Syringe, Model 0322G1.5	Syringex Medical, Inc.	MEG	Class II	2003-06-23
K031038	Advia Centaur B-Type Natriuretic Peptide (Bnp) Assay	Medrad, Inc.	NBC	Class II	2003-06-23
K031015	Embryoglue	Vitrolife Sweden AB	MQL	Class II	2003-06-23
K030935	Berkeley V-10 Vacuum Curettage System	Acmi Corporation	HHI	Class II	2003-06-23
K030218	Per, Model Memo	Medical Monitors, Inc.	DXH	Class II	2003-06-23
K023333	Multiple, Male Latex Condom [52Mm or 56Mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 (Dotted/ribbed/contour	Pleasure Latex Products Sdn. Bhd.	HIS	Class II	2003-06-23
K031872	Ultra-High Energy General Purpose Collimator (Uhgp) [for Cardiac Imaging]	Philips North America LLC	KPS	Class II	2003-06-20
K031871	Autobone	GE Medical Systems Europe	JAK	Class II	2003-06-20
K031825	C.cam	Danish Diagnostic Development A/S	KPS	Class II	2003-06-20
K031675	Smith & Nephew Dyonics Electroblade Resector	Smith & Nephew, Inc.	GEI	Class II	2003-06-20
K031653	Datex-Ohmeda Hmef 750	GE Healthcare	CAH	Class II	2003-06-20
K031606	Access Immunoassay System Rubella Igg Assay	Siemens Healthcare Diagnostics Inc.	LFX	Class II	2003-06-20
K031468	Temporary Titanium Aneurysm Clip	Cardinalhealth	HCH	Class II	2003-06-20
K031391	HF Module with Transducers	Ophthalmic Technologies, Inc.	IYO	Class II	2003-06-20
K031311	Integradweb by Dynamic Imaging, Inc.	Dynamic Imaging, Inc.	LLZ	Class II	2003-06-20
K031248	Consultiva Report Station, Model Rs-1	Miramedica, Inc.	LLZ	Class II	2003-06-20
K031198	Scanx 10	Air Techniques, Inc.	MQB	Class II	2003-06-20
K031095	Sense Body Coil	Philips North America LLC	MOS	Class II	2003-06-20
K030963	Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe, Also Known as the Trufill Dcs Orbit Detachable Coil System	Cordis Neurovascular, Inc.	HCG	Class II	2003-06-20
K030944	Edwards Lifesciences Percutaneous Sheath Introducers with Oligon Material	Edwards Lifesciences LLC	DYB	Class II	2003-06-20
K030330	Ctxa Hip Extended Reference Data	Mindways Software, Inc.	KGI	Class II	2003-06-20
K024259	Pulsed Light Therapy System, Model# UV-300	New Star Lasers, Inc.	GEX	Class II	2003-06-20
K024243	Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406	Medtronic, Inc.	MCW	Class II	2003-06-20
K024189	Nlite System, Model#: A00-1025/A00-1033	Icn Photonics, Ltd.	GEX	Class II	2003-06-20
K031626	Angiodynamics, Inc. Morpheus Picc and Procedure Kit	Boston Scientific Corporation	LJS	Class II	2003-06-19
K031571	Empowercta Injector System, Models 9930 & 9910 & 9825	E-Z-EM, Inc	IZQ	Class II	2003-06-19
K031353	Solution Face Masks	A Plus International, Inc	FXX	Class II	2003-06-19
K031177	Diastat Anti-B2 Glycoprotein 1 Igm, Model Fbgp 100M	Axis-Shield Diagnostics, Ltd.	MSV	Class II	2003-06-19
K031164	Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-Blv	Oscor Inc.	DTD	Class II	2003-06-19
K031041	Fluency Tracheobronchial Stent Graft	Bard Peripheral Vascular Inc	JCT	Class II	2003-06-19
K031029	Arthrocare Bipolar Electrosurgery System	ArthroCare Corporation	FAS	Class II	2003-06-19
K030946	Hemcon Bandage OTC; Hemcon Cath/aid	Hemcon, Inc.	QSY	Unclassified	2003-06-19
K030916	Ufi Gel Hard C	Voco GmbH	EBI	Class II	2003-06-19
K030900	Inion Otps Biodegradable Fixaton System	Inion Oy	HWC	Class II	2003-06-19
K030897	Skinstation	Radiancy (Israel), Ltd.	GEX	Class II	2003-06-19
K030401	Disposable M2-Pe Microkeratome Blades	Oasis Medical, Inc.	HNO	Class I	2003-06-19
K030174	Genicon Laparoscopes	Genicon, LC	GCJ	Class II	2003-06-19
K024372	Cp Medical Bone Wax	Cp Medical	MTJ	Unclassified	2003-06-19
K024093	Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and Nd:yag Laser Systems	Lumenis Ltd	GEX	Class II	2003-06-19
K023896	C-1890	Anodia Systems	EIA	Class I	2003-06-19
K023815	C-1805M	Anodia Systems	EIA	Class I	2003-06-19
K023036	Care Ets	Care Rehab and Orthopaedic	IPF	Class II	2003-06-19
K031605	Intelijet Fluid Management System Hermes-Ready	Smith & Nephew, Inc.	HRX	Class II	2003-06-18
K031510	Nim-Spine	Medtronic Xomed, Inc.	ETN	Class II	2003-06-18
K031452	Oria Spinal Clip System, Sacral Connector, Models Ca03 and Ao03	Ortho Tec, LLC	KWP	Class II	2003-06-18
K031443	Lsi Solutions Suture Quick Load Products	Lsi Solutions Inc.	NEW	Class II	2003-06-18
K031233	Andiodynamics, Inc. Elvs Procedure Kit	Boston Scientific Corporation	GEX	Class II	2003-06-18
K031231	Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis	Bio-Rad	JJW	Class I	2003-06-18
K031005	Lumend Frontrunner Gw Cto Catheter	Lumend, Inc.	PDU	Class II	2003-06-18
K030883	Omnilux Blue	Photo Therapeutics Limited	GEX	Class II	2003-06-18