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 1403 of 3531

510(k) clearances, page 1403 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040181	Access Dhea-S Reagent Assay	Siemens Healthcare Diagnostics Inc.	JKC	Class I	2004-03-24
K040156	Ifl Professional System, Model C100	Cyden Limited	GEX	Class II	2004-03-24
K040110	Easy Loop, Model Ezl-01	Tools for Surgery, LLC	EZP	Class II	2004-03-24
K040051	Megvision, Model Eq1000c Series	Eagle Technology, Inc.	OLX	Class II	2004-03-24
K040050	Instatrak System with Multiple Dataset Navigation, Model It3500	GE Medical Systems Navigation and Visualization in	LLZ	Class II	2004-03-24
K034035	3I Patient-Specific Overdenture Bar	ZimVie US Corp LLC	NHA	Class II	2004-03-24
K033644	Endoboy	Geyser S.A.	GCJ	Class II	2004-03-24
K033173	Micro Targeting Electrode	FHC, Inc.	GZL	Class II	2004-03-24
K032657	Truetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)	Home Diagnostics, Inc.	NBW	Class II	2004-03-24
K040691	Intra Oral Camera System & Accessories, Model Win-100D	Win-Us Technology Co., Ltd.	EIA	Class I	2004-03-23
K040634	Robertsite Vial Adapter, Model 245700021	Halkey-Roberts Corporation	LHI	Class II	2004-03-23
K040532	Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)	Zi BO Hong Wang Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2004-03-23
K040531	Terumo Surguard2 Safety Needle	Terumo Medical Corp.	FMI	Class II	2004-03-23
K040462	Trigen Trochanteric Antegrade Nail	Smith & Nephew, Inc.	HSB	Class II	2004-03-23
K040448	Gentle Skin and (Multiple Labels) Latex Examination Glove, Powder Free, Polymer Coated with Protein Claim	Rosner-Mautby Meditrade(Thailand), Ltd.	LYY	Class I	2004-03-23
K040306	High Voltage Pulsed Stimulator, Model Bmls02-7	BioMedical Life Systems Inc.	IPF	Class II	2004-03-23
K040284	Sustain Radiolucent Spacer	Globus Medical, Inc.	MQP	Class II	2004-03-23
K040258	Synthes Medium External Fixation System-Mr Safe	Synthes (USA) Products LLC	KTT	Class II	2004-03-23
K040250	Bone-Lok Hp Washer	Triage Medical, Inc.	HTN	Class II	2004-03-23
K040064	Newmedical Micro Bone Distractor/fixator	Newmedical Technology, Inc.	KTT	Class II	2004-03-23
K034045	Oral Osteodistraction Distraction Rod Appliances, Rod 4	Oral Osteodistraction, L.P.	MQN	Class II	2004-03-23
K033149	Ultimate Professional Continuous Flow Colonic System	Ultimate Concepts, Inc.	KPL	Class II	2004-03-23
K033109	Ellys and Aurys Vertebral Body Replacements	Scient'X	MQP	Class II	2004-03-23
K031304	Sydney Ivf Pvp	Cook Incorporated	MQL	Class II	2004-03-23
K024213	Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392e, 65 22 572 E397e, 65 03 655	Siemens Medical Solutions USA, Inc.	DSI	Class II	2004-03-23
K040640	Model 475 - 8 Channel T/r Phased Array Lower Extremity Coil	Igc-Medical Advances, Inc.	MOS	Class II	2004-03-22
K040586	Mesacup Test Mpo, Model 11053	Rhigene, Inc.	MOB	Class II	2004-03-22
K040577	Somatom Project P30l	Siemens Medical Solutions USA, Inc.	JAK	Class II	2004-03-22
K040541	Mammosource High Dose Rate (Hdr) Remote Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	2004-03-22
K040205	Intra-Lock International Angled Prosthetic Abutments	Intra-Lock International	NHA	Class II	2004-03-22
K040204	Zyoptix Xp Microkeratome	Bausch & Lomb Incorporated	HNO	Class I	2004-03-22
K040159	Apm Blood Pressure Monitor, Model Bp108a	Asia Pacific Microsystems, Inc.	DXN	Class II	2004-03-22
K040002	Microlife Wrist Watch Blood Pressure Monitor, Model Bp3ax1	Microlife Intellectual Property Gmb	DXN	Class II	2004-03-22
K034050	Cordis Optease Vena Cava Filter, Models 466-F220a and 466-F220b; Retrievable Catheter, Model 466-C220f	Cordis US Corp.	DTK	Class II	2004-03-22
K033977	Zeus Scientific, Inc., Athena Multi-Lyte Tpo/tg Igg Test System	Zeus Scientific LLC	JZO	Class II	2004-03-22
K033694	Infinity Modular Monitors Vf4 Modifications	Draeger Medical Systems, Inc.	MHX	Class II	2004-03-22
K033454	Brahms Diagnostica Lumitest Trak Human	Brahms Diagnostica, LLC	JZO	Class II	2004-03-22
K033000	Next Generation Portable Therapeutic Liquid Oxygen System	Essex Cryogenics of Missouri, Inc.	BYJ	Class II	2004-03-22
K032292	Bioteque A.v. Fistula Needle Set with Safety Flex	Bioteque Corp.	FOZ	Class II	2004-03-22
K031487	Model Avant 2120 Pulse Oximeter and Nibp	Nonin Medical, Inc	DXN	Class II	2004-03-22
K040548	Aegis Ortho Light-Cured Orthodontic Adhesive	Harry J. Bosworth Co.	DYH	Class II	2004-03-19
K040547	Aegis Ortho Dual-Cured Orthodontic Adhesive	Harry J. Bosworth Co.	DYH	Class II	2004-03-19
K040422	Modification to Verte-Stack	Medtronic Sofamor Danek	MQP	Class II	2004-03-19
K040373	Kerato Analyzer (Eka)	Konan Medical, Inc.	NQE	Class II	2004-03-19
K040359	Hemosil Special Test Controls Level 1 & 2	Instrumentation Laboratory Co.	JPA	Class II	2004-03-19
K040229	A&d Medical Lifesource Digital Blood Pressure Monitors, Model Ub-328	A and D Engineering, Inc.	DXN	Class II	2004-03-19
K040173	Pediatric Aortic Root Cannula	Medtronic Perfusion Systems	DWF	Class II	2004-03-19
K040099	Bd Phoenix Automated Microbiology System	Becton Dickinson & Co	LON	Class II	2004-03-19
K034024	Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders	Bisco Inc	EBI	Class II	2004-03-19
K033998	Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V	Masimo Corporation	DQA	Class II	2004-03-19