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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 190 of 3526

510(k) clearances, page 190 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K232280	NextAR™ TSA Platform	Medacta International SA	SBF	Class II	2023-10-29
K233270	AcuNav Crystal Ultrasound Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2023-10-28
K230418	Mighty Wire Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2023-10-28
K233318	AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)	Boston Scientific Corporation	KNS	Class II	2023-10-27
K233292	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	Inomed Medizintechnik GmbH	GWF	Class II	2023-10-27
K233241	SOLACE Sacroiliac Fixation System	Ht Medical, LLC dba Xenix Medical	OUR	Class II	2023-10-27
K233220	EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)	Senorx, Inc.	KNW	Class II	2023-10-27
K233207	Polaris X™ Unidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	DRF	Class II	2023-10-27
K233187	Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)	STERIS Corporation	JOJ	Class II	2023-10-27
K233090	DEKA AGAIN PRO family	El.En S.p.A.	GEX	Class II	2023-10-27
K232667	OR3O Dual Mobility Liners	Smith & Nephew, Inc.	LPH	Class II	2023-10-27
K232618	Aurora Surgiscope System	Rebound Therapeutics, Corporation	GWG	Class II	2023-10-27
K232393	BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge	Proedge Dental Products	QYJ	Class I	2023-10-27
K232348	RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System	Mirus, LLC	OVE	Class II	2023-10-27
K232346	Digital Expert Access with Remote Scanning	GE Healthcare	LNH	Class II	2023-10-27
K232045	MeVis Liver Suite	Mevis Medical Solutions AG	JAK	Class II	2023-10-27
K231934	GIA™ Stapler with Tri-Staple™ Technology	Medtronic, Inc.	GAG	Class II	2023-10-27
K231908	45 Micron Polyisoprene Condom	Suretex, Ltd.	MOL	Class II	2023-10-27
K231761	PodSKAN HF Diagnostic X-ray System	Skanray Technologies Limited	KPR	Class II	2023-10-27
K231545	hearOAE	Hearx SA (Pty), Ltd.	EWO	Class II	2023-10-27
K231494	CoreLink Robotic Navigation Instruments	Corelink, LLC	OLO	Class II	2023-10-27
K231310	Electronic Blood Pressure Monitor	Shenzhen Jumper Medical Equipment Co.,Ltd.	DXN	Class II	2023-10-27
K231214	LIAISON VZV IgG HT, LIAISON Control VZV IgG HT	Diasorin Inc.	LFY	Class II	2023-10-27
K231165	Shina Syringe; Shina Safety Syringe	Shina Med Corporation	MEG	Class II	2023-10-27
K230854	SwiftMR	AIRS Medical Inc.	LLZ	Class II	2023-10-27
K230826	Modius Sleep	Neurovalens	QJQ	Class II	2023-10-27
K230490	PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT	Dongguan Hunter Electronic Technology Co., Ltd.	OLP	Class II	2023-10-27
K230300	i-STAT CG8+ cartridge with the i-STAT 1 System	Abbott Medical	JFP	Class II	2023-10-27
K230285	i-STAT CG8+ cartridge with the i-STAT 1 System	Abbott Medical	CHL	Class II	2023-10-27
K230275	i-STAT CG8+ cartridge with the i-STAT 1 System	Abbott Medical	JGS	Class II	2023-10-27
K223541	Cold/Hot Compression	JKH Health Co., Ltd.	IRP	Class II	2023-10-27
K222459	Centrix FluoroSilver Silver Diamine Fluoride 38%	Centrix, Inc.	PHR	Class II	2023-10-27
K220493	Plaxpot Multi Plasma	Gcs Co. Limited	QVJ	Class II	2023-10-27
K213146	Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen	Jiangsu Rongye Technology Co.,Ltd	JKA	Class II	2023-10-27
K233417	AllTest Fentanyl Urine Test Cassette	Hangzhou AllTest Biotech Co.,Ltd	NGL	Class II	2023-10-26
K233234	PressON Spinal Fixation System	Nexus Spine, L.L.C.	NKB	Class II	2023-10-26
K233223	OGmend® Implant Enhancement System	woven Orthopedic Technologies	QVI	Class II	2023-10-26
K233170	cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)	AtriCure, Inc.	GXH	Class II	2023-10-26
K233101	Luja Coude (20108 Male CH18 - large packaging)	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2023-10-26
K233091	Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)	Spectrum Medical Inc	KFM	Class II	2023-10-26
K232500	Lumify Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2023-10-26
K232271	SIMDA abutment	Simda Co.,Ltd.	NHA	Class II	2023-10-26
K231737	ANAX™ 5.5 Spinal System	Innosys Co., Ltd.	NKB	Class II	2023-10-26
K231685	TE Air Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2023-10-26
K231595	Electric Breast Pump	Shenzhen Changkun Technology Co., Ltd.	HGX	Class II	2023-10-26
K231579	Molli 2	Molli Surgical, Inc.	NEU	Class II	2023-10-26
K231550	Sontro® OTC Hearing Aids (AI)	Soundwave Hearing, LLC	QUH	Class II	2023-10-26
K230662	Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs	Zhonghong Pulin Medical Products Co.,Ltd.	LZA	Class I	2023-10-26
K230559	Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)	MEDLINE INDUSTRIES, LP - Northfield	BTT	Class II	2023-10-26
K230500	Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)	Jiangsu Maxf Electric Appliance Co.,Ltd	IRP	Class II	2023-10-26