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 854 of 3530

510(k) clearances, page 854 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122633	Toxcup Drug Screen Cup	Branan Medical Corp.	LDJ	Class II	2013-02-07
K122587	Brk Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208	Abbott Medical	DRC	Class II	2013-02-07
K122554	Genasis Scanview System	Applied Spectral Imaging, Ltd.	NTH	Class II	2013-02-07
K121818	Osteofab Patient Specific Cranial Device	Oxford Performance Materials, Inc.	GXN	Class II	2013-02-07
K121050	0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush Syringe	Becton Dickinson & Co	NGT	Class II	2013-02-07
K120922	Guardian Dysphagia Dual Channel Nmes Unit	Spectramed, LLC	IPF	Class II	2013-02-07
K120708	Onetouch Verio Sync Blood Glucose Monitoring System	Cilag GmbH International	NBW	Class II	2013-02-07
K120701	M2 Wrist MRI System	Aspect Imaging Ltd	LNH	Class II	2013-02-07
K120558	Onetouch Reveal Diabetes Management Application	Lifescan, Inc.	NBW	Class II	2013-02-07
K130041	Sheathes Sterile Ultrasound Gel	Sheathing Technologies Inc	MUI	Class II	2013-02-06
K123992	Aplio 500/400/300 V3.0	Toshibamedical Systems Corporation	IYN	Class II	2013-02-06
K123970	Caas Intravascular	PIE Medical Imaging B.V.	LLZ	Class II	2013-02-06
K123865	Visual-Ice Cryoablation System	Galil Medical Ltd.	GEH	Class II	2013-02-06
K123460	Trc-Nw300 Non-Mydriatic Retinal Camera	Topcon Healthcare, Inc.	HKI	Class II	2013-02-06
K123326	Sherpa Pak Cardiac Transport System	Paragonix Technologies Inc.	MSB	Class II	2013-02-06
K123125	Ge Datex-Ohmeda Avance Cs2	GE Healthcare	BSZ	Class II	2013-02-06
K122879	Eeger4 Model 4.3	EEG Software LLC	HCC	Class II	2013-02-06
K122718	Bd Veritor(tm) System for Rapid Detection of Group a Strep	Becton Dickinson & Co	GTY	Class I	2013-02-06
K121409	Asahi Rexeed-Sx/lx Series Dialyzer	Asahi Kasei Medical Co., Ltd.	KDI	Class II	2013-02-06
K130016	Lifespan Eptfe Vascular Graft	LeMaitre Vascular Inc.	DSY	Class II	2013-02-05
K123434	Profemur Z Classic Stems	Wrightmedicaltechnologyinc	LZO	Class II	2013-02-05
K123309	Giraffe and Panda Warmers	GE Healthcare	FMT	Class II	2013-02-05
K123217	Cardeascreen	Cardea Associates, Inc.	DPS	Class II	2013-02-05
K123215	Viscostat Clear	Ultradent Products Inc.	MVL	Unclassified	2013-02-05
K123138	Pass Lp Spinal System	Medicrea International	OSH	Class II	2013-02-05
K123114	Ethicon Securestrap Open Absorbable Strap Fixation Device	Ethicon, Inc	GDW	Class II	2013-02-05
K123050	Egens One Step Hcg Urine Pregnancy Test Kit(s) (Strip, Cassette, Midstream I and Midstream II)	Nantong Biotechnology Co., Ltd.	LCX	Class II	2013-02-05
K122805	Parcus Draw Tight 1.8Mm Single-Loaded Suture Anchor	Parcus Medical, L.L.C.	MBI	Class II	2013-02-05
K122781	Reliamax Gastrointestinal Anastomosis and Reload	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2013-02-05
K122520	Digital Thermomter	Taidoc Technology Corporation	FLL	Class II	2013-02-05
K122183	Augment and Screw, Psa Type	United Orthopedic Corp.	JWH	Class II	2013-02-05
K121453	A-Grix Te Resorable Bone Void Filler	Ag Digital Technology Corp.	MQV	Class II	2013-02-05
K123704	Automated Endoscope Leak Tester	Olympus Medical Systems Corp.	PCV	Class II	2013-02-04
K123170	Vari-Pass Variable Length Access Sheath	Olympus Surgical Technologies America	KNY	Class II	2013-02-04
K122046	Wrist Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2013-02-04
K120804	Cianna Medical Tissue Marker and Delivery System	Cianna Medical, Inc.	PBY	Class II	2013-02-04
K123995	Microdose Si	Philips Digital Mammography Sweden AB	MUE	Class II	2013-02-01
K123757	Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim, Natural Color	Assurguard Sdn. Bhd.	LYY	Class I	2013-02-01
K123610	E-Cube 15	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2013-02-01
K123578	Anterior Cervical Plate System	Weigao Orthopaedic Device Co., Ltd.	KWQ	Class II	2013-02-01
K123545	Incoris Tzi	Sirona Dental Systems GmbH	EIH	Class II	2013-02-01
K123538	Epien Root Canal Cleanser	Epien Medical, Inc.	KJJ	Unclassified	2013-02-01
K123519	Invivo Dental	Anatomage, Inc.	LLZ	Class II	2013-02-01
K123420	Syngo, Breast Care	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2013-02-01
K123362	Milagro Advance Interference Screw	DePuy Mitek, Inc.	HWC	Class II	2013-02-01
K123134	Easyspine System	Ldr Spine USA	NKB	Class II	2013-02-01
K123033	Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B	Rocket Medical	DWM	Class II	2013-02-01
K122865	Vivix-S Wireless	Vieworks Co., Ltd.	MQB	Class II	2013-02-01
K122853	Novel Fit and Fill Stem	Howmedica Osteonics Corp	MEH	Class II	2013-02-01
K122550	Ics Impulse	Natus Medical Denmark ApS	GWN	Class II	2013-02-01