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 876 of 3530

510(k) clearances, page 876 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121665	Bencox Foret & Bencox Delta	Corentec Co., Ltd.	LZO	Class II	2012-09-25
K121580	Surelase CO2 Laser System	Clinicon Corp.	GEX	Class II	2012-09-25
K121305	Sterling Medical Impulse 3 Stimulator	Armstrong Industries, Inc. Dha Mediquip Int. Dha S	GZJ	Class II	2012-09-25
K121219	Attain Clarity 6225 Venogram Balloon Catheter	Medtronic, Inc.	DQY	Class II	2012-09-25
K120907	Zoll R Series	ZOLL Medical Corporation	MKJ	Class III	2012-09-25
K113120	Chf-Y0005	Olympus Medical Systems Corp.	FBN	Class II	2012-09-25
K122259	Blood Pressure Monitor with Stethoscope	Hangzhou Reli-On Co., Ltd.	DXQ	Class II	2012-09-24
K121707	Lew Mdi O-Ball Collared Implant,	Park Dental Research Corp	DZE	Class II	2012-09-24
K121656	Gemini Lithotripter	Dornier Medtech America, Inc.	LNS	Class II	2012-09-24
K121021	Inomax Ds (Delivery System)	Mallinckrodt Manufacturing LLC	MRN	Class II	2012-09-24
K120938	The Pl-1064 Laser System	Sheaumann Laser, Inc.	PDZ	Class II	2012-09-24
K113836	Benehold Chg Transparent Film Dressing (10X12cm) (8.5X12cm) (6.5X7 Cm)	Avery Dennison Belgie Bvba	FRO	Unclassified	2012-09-24
K112449	Quikresponse One Step Midstream Early Pregrancy Test	Tianjin New Bay Bioresearch Co., Ltd.	LCX	Class II	2012-09-24
K122327	Voluson E6/e8/e8expert/e10	GE Healthcare	IYN	Class II	2012-09-21
K122109	Aquilion One Vision, V4.90	Toshiba America Medical Systems, In.C	JAK	Class II	2012-09-21
K122089	Ostial Pro Stent Positioning System	Merit Medical Systems, Inc.	DQX	Class II	2012-09-21
K122026	Prism Acquire Prism Process Prism View	Prism Clinical Imaging, Inc.	LNH	Class II	2012-09-21
K121848	Split Cath III 24Cm Split Cath III 24Cm Split Cath III 32Cm Cath III 36Cm Split Cath III 40Cm and 55Cm	Medical Components, Inc.	MSD	Class II	2012-09-21
K121773	Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode	Biomerics	GXI	Class II	2012-09-21
K121674	Aspire Hd Plus, Aspire Hd-S	FUJIFILM Healthcare Americas Corporation	MUE	Class II	2012-09-21
K121589	Biomet Microfixation Facial Plating System	Biomet Microfixation	JEY	Class II	2012-09-21
K121568	Dali Spinal Fixation System	Accel Spine	NKB	Class II	2012-09-21
K121558	Diazyme Hscrp Poc Test Kit	Diazyme Laboratories, Inc.	DCK	Class II	2012-09-21
K121260	Trooper Oxygen Concentrator	Vbox, Inc.	CAW	Class II	2012-09-21
K121150	Alma Lasers Family of Pixel RF Tips	Alma Lasers Ltd.	GEI	Class II	2012-09-21
K121005	Adiprep Adipose Transfer System	Terumo BCT, Ltd	MUU	Class II	2012-09-21
K120943	Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown Tip Speedlock Hip Pathfinder	ArthroCare Corporation	MBI	Class II	2012-09-21
K112958	Humid-Vent Hepa	Teleflex Medical	CAH	Class II	2012-09-21
K111142	Echosoft(tm)	Echometrix, LLC	LLZ	Class II	2012-09-21
K122558	Ultrasafe Passive Needle Guard	Safety Syringes, Inc.	MEG	Class II	2012-09-20
K122545	Cg+ Arrow Picc Powered by Arrow Vps Stylet	Arrow International (Subsidiary of Teleflex Inc.)	LJS	Class II	2012-09-20
K122541	Orthofix Contours Proimal Humeral Plate (Php)	Orthofix SRL	KTW	Class II	2012-09-20
K122378	Nextgen Altius Oct System	Biomet Spine (Aka Ebi, LLC)	KWP	Class II	2012-09-20
K122373	Neomed Oral/enteral Syringe	Halyard Health	FMF	Class II	2012-09-20
K122021	Sterispine Lc Cage	Safe Orthopaedics	MAX	Class II	2012-09-20
K121926	Blue, Latex Powder Free Examination Gloves, Tested for Use with Chemotherapy Drugs with Protein Labling Claim (50Ug/dm	Northstar Healthcare Holdings	LZC	Class I	2012-09-20
K121850	Typhoon(TM) Facet Screw Fixation System	Choicespine, LP	MRW	Unclassified	2012-09-20
K121729	E-Cube 7	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2012-09-20
K121724	Endolight LED 1.1 Endolightled 1.2	Richard Wolf Medical Instruments Corp.	FCW	Class II	2012-09-20
K121676	1.5T Signa Hdxt 3.0T Signa Hdxt Signa Vibrant	GE Healthcare	LNH	Class II	2012-09-20
K121590	Vestibular Analysis Apparatus	Capacity Sports, LLC	LXV	Unclassified	2012-09-20
K121262	Medeflush Normal Saline i.v. Flush Syringe-Sterile Field Ready	Medefil, Inc.	NGT	Class II	2012-09-20
K121056	Mets Modular Proximal Femur	Stanmore Implants Worldwide, Ltd.	JDI	Class II	2012-09-20
K120867	Viper and Expedium Navigated Instruments	Medos International SARL	OLO	Class II	2012-09-20
K120501	Champ Champ Transit	Convaid Products LLC	IOR	Class I	2012-09-20
K120462	Audicor Cpam with Sdb (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)	Inovise Medical, Inc.	MLO	Class II	2012-09-20
K113863	Quanta Flash Dgp Iga, Quanta Flash Dgp Igg, Quanta Flash Dgp Iga Calibrators, Quanta Flash Dgp Igg Calibrators	Inova Diagnostics, Inc.	MST	Class II	2012-09-20
K113720	Randox Maternal Control, Levels 1, 2 and 3	Randox Laboratories, Limited	JJY	Class I	2012-09-20
K113282	Cerasorb Dental,ceradorb M Dental, Cerasorb Perio	Riemser Arzeimittel AG	LYC	Class II	2012-09-20
K122622	Enduramesh	Lucero Medical, LLC	MQP	Class II	2012-09-19