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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 264 of 3528

510(k) clearances, page 264 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222005	S.I.N. Instrument Kits	S.I.N. Implant System Ltda	KCT	Class II	2022-09-29
K221918	ReFlow System Mini	Anuncia Medical, Inc.	JXG	Class II	2022-09-29
K221637	Surgical Gown (Sterile); Surgical Gown (Non-sterile)	Allmed Medical (Hubei) Protective Products Co., Ltd	FYA	Class II	2022-09-29
K221496	Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2022-09-29
K221375	CureSight-CS100	Novasight	QQU	Class II	2022-09-29
K221300	Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2022-09-29
K220080	CogNet QmTRIAGE	Medcognetics, Inc	QFM	Class II	2022-09-29
K213716	InnovaBurn	Triad Life Sciences, Inc.	KGN	Unclassified	2022-09-29
K213417	Ghost Spacer System	Life Spine	MAX	Class II	2022-09-29
K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws	Smith & Nephew, Inc.	JDO	Class II	2022-09-29
K213034	SpineAR SNAP	Surgical Theater Inc	SBF	Class II	2022-09-29
DEN200067	INNOVANCE VWF Ac	Siemens Healthcare Diagnostics Products Limited	QTY	Class II	2022-09-29
K222627	EndoGI S-Path Biliary Stent System	Endo GI Medical	FGE	Class II	2022-09-28
K222615	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate	STERIS Corporation	MED	Class II	2022-09-28
K222482	AGILON XO Shoulder System	implantcast GmbH	KWT	Class II	2022-09-28
K222442	DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)	Anhui Bytech Medical Supplies Co., Ltd.	LYZ	Class I	2022-09-28
K222329	BriefCase	Aidoc Medical Ltd.	QAS	Class II	2022-09-28
K222328	SteriCUBE® Multiple Tray Sterilization Systems	Stericube, LLC	KCT	Class II	2022-09-28
K222316	IPL Hair Removal Device	Shenzhen Goodwind Technology Development CO., Ltd	OHT	Class II	2022-09-28
K221906	TROJAN Fire & Ice lubricated male natural rubber latex condom	Church & Dwight Co., Inc.	HIS	Class II	2022-09-28
K221548	Dental Air Polishing Handpiece	Guilin Woodpecker Medical Instrument Co., Ltd	EFB	Class I	2022-09-28
K221397	MitraClip G4 Steerable Guide Catheter	Abbott Medical	DRA	Class II	2022-09-28
K220245	Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)	Contec Medical Systems Co., Ltd.	KNG	Class II	2022-09-28
K220081	Core-Sport	Incore Co., Ltd.	OTJ	Class II	2022-09-28
K212143	Neteera 130H/131H Vital Sign Monitoring Sensor	Neteera Technologies Ltd	DRT	Class II	2022-09-28
K211902	InnovaMatrix PD	Triad Life Sciences, Inc.	KGN	Unclassified	2022-09-28
K222661	Digital Radiography CXDI-CS01	Canon, Inc.	MQB	Class II	2022-09-27
K222648	5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)	Philips North America LLC	IYN	Class II	2022-09-27
K221738	NS-HGlio	Neosoma, Inc.	QIH	Class II	2022-09-27
K221360	Medline UNITE® Medial Malleolus Peg Plate System	MEDLINE INDUSTRIES, LP - Northfield	HRS	Class II	2022-09-27
K221211	Infrared thermometer	Shenzhen Yolanda Technology Co., Ltd.	FLL	Class II	2022-09-27
K220831	Dental Implantation Systems, Dental Electrical Motors	Foshan Coxo Medical Instrument Co., Ltd.	EBW	Class I	2022-09-27
K220785	Clean Connecting Tube	Yangzhou Fartley Medical Instrument Technology Co., Ltd	OCX	Class II	2022-09-27
K220342	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3	Canon Medical Systems Corporation	OWB	Class II	2022-09-27
K213883	NanoZoomer S360MD Slide scanner system	Hamamatsu Photonics K.K.	PSY	Class II	2022-09-27
K212561	Mtx-C1	Ilooda Co,., Ltd.	GEI	Class II	2022-09-27
K222655	OtoSight Middle Ear Scope	Photonicare Inc	QJG	Class II	2022-09-26
K222602	Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)	Zhuhai Pusen Medical Technology Co., Ltd.	FAJ	Class II	2022-09-26
K222266	Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)	Jingzhou Haixin Green Cross Medical Products Co.,Ltd	FXX	Class II	2022-09-26
K221631	Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V	Olympus Medical Systems Corp.	EOQ	Class II	2022-09-26
K221473	Flowart	Asset Medikal Tasarim AS.	FPA	Class II	2022-09-26
K221062	RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device	Bionime Corporation	QRL	Class II	2022-09-26
K220795	Qt ECG	QT Medical, Inc	DXH	Class II	2022-09-26
K220116	Auryon Atherectomy Catheters	Eximo Medical Ltd	MCW	Class II	2022-09-26
K214015	Palm NRG cellulite body device (model: Palm NRG body device)	Heat in a Click LLC	PBX	Class II	2022-09-26
K222629	Resonic Rapid Acoustic Pulse Device	Zeltiq Aesthetics Inc	GEX	Class II	2022-09-25
K222693	Single-use medical latex examination gloves (LG100)	Fitone Latex Products Co., Ltd. Guangdong	LYY	Class I	2022-09-24
K222342	Betel Gloves Nitrile Examination Glove Powder Free	Betel Care Sdn. Bhd.	LZA	Class I	2022-09-24
K222294	Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid	Onetexx Sdn Bhd	LZA	Class I	2022-09-24
K221887	Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color	Guangdong Kingfa Sci.&tech.co.,Ltd.	LZA	Class I	2022-09-24