FDA device clearances in China: 1,126 since Nov 2024

Name: FDA device clearances for applicants in China
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in China: 1,126 rows for $56.30, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 46 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/country/china, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 1,126 device decisions for applicants in China from November 12, 2024 to October 30, 2026: 1,126 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 605 applicants. The newest, K263860 on October 30, 2026, is Shining3D Clear Aligner System from Hangzhou SHINING3D Dental Technology Co., Ltd..

The request: Every new FDA device clearance or approval for a company in China, with its address, the device and the product code. $10 of credit on sign-up, no card.

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SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

1,126Decisions
1,126510(k) and De Novo
0PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 1,126, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	K263860	Shining3D Clear Aligner System	Hangzhou SHINING3D Dental Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
October 30, 2026	K262470	Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)	Changsha Anxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NGX	accessdata.fda.gov
October 30, 2026	K260738	Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System	Changsha Sinocare, Inc.	China	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 30, 2026	K260575	AutoGel Pad (400-046,400-005)	Top-Rank Health Care Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MUI	accessdata.fda.gov
October 30, 2026	K260354	Foster Plus-22L (SNK/CE-F22)	Zhejiang Fomos Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FLE	accessdata.fda.gov
October 29, 2026	K263065	MicroPort Total Knee System	Suzhou Microport Orthorecon Co., Ltd.	China	Substantially Equivalent	510(k) traditional	JWH	accessdata.fda.gov
October 29, 2026	K262756	Zirconia Dental Ceramics and Staining Solution	Fanen New Materials Technology (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 29, 2026	K262437	Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)	Zhejiang Geyi Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
October 29, 2026	K260427	Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)	Lumicare Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	SCS	accessdata.fda.gov
October 28, 2026	K263313	Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)	Shenzhen Rainbow Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
October 28, 2026	K263005	Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)	Anhui Longway Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 28, 2026	K261676	uPMR Zenith	Shanghai United Imaging Healthcare Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OUO	accessdata.fda.gov
October 28, 2026	K261636	Microwave Ablation Antennas	Canyon Medical, Inc.	China	Substantially Equivalent	510(k) traditional	NEY	accessdata.fda.gov
October 28, 2026	K260670	YUWELL® Electronic Blood Pressure Monitor	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
October 27, 2026	K262349	Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)	Risu Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 27, 2026	K261740	Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)	Robotrak Technologies Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MYC	accessdata.fda.gov
October 26, 2026	K262984	Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06...	Shenzhen Bway Tech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHS	accessdata.fda.gov
October 26, 2026	K262627	Fractional CO2 Laser Therapy System (Z121)	Sanhe PERFECTLASER Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 26, 2026	K262280	Mouth guard	Dongguan Yiyao Science & Technology Development Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OBR	accessdata.fda.gov
October 26, 2026	K261156	Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 26, 2026	K261155	Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 26, 2026	K260350	Cysto-Urethroscopes and accessories	Hangzhou Hawk Optical Electronic Instruments Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FJL	accessdata.fda.gov
October 23, 2026	K262752	Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)	Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHS	accessdata.fda.gov
October 23, 2026	K260275	Mobile Dental Solution (Model: DS50, DS70, DS90)	Guangdong JINME Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIA	accessdata.fda.gov
October 23, 2026	K260251	BreathCare PAP III (YH-390N)	Suzhou Yuyue Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	BZD	accessdata.fda.gov
October 22, 2026	K262701	PicoPeak Picosecond Nd:Yag Laser System (Bella-9)	Beijing Sea Heart International Science and Technologyco.Ltd	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 22, 2026	K260686	Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter	Zylox Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PNO	accessdata.fda.gov
October 22, 2026	K260230	Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)	Suzhou Medical Appliance Factory	China	Substantially Equivalent	510(k) traditional	BWK	accessdata.fda.gov
October 21, 2026	K261531	PV-iCurve Pro	Perception Vision Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LLZ	accessdata.fda.gov
October 20, 2026	K262664	Rongjian Self-adhesive Electrode	Bozhou Rongjian Medical Appliance Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GXY	accessdata.fda.gov
October 20, 2026	K262628	Picosecond Laser treatment system (Z180)	Sanhe PERFECTLASER Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 19, 2026	K262932	AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)	Shenzhen Accompany Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHS	accessdata.fda.gov
October 16, 2026	K263254	Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)	Xiamen Compower Medical Tech. Co., Ltd.	China	Substantially Equivalent	510(k) special	BTM	accessdata.fda.gov
October 16, 2026	K261585	Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound...	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 16, 2026	K261574	Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)	Hong Qiangxing (Shenzhen) Electronics Limited	China	Substantially Equivalent	510(k) traditional	NUH	accessdata.fda.gov
October 15, 2026	K262674	Giranel Guiding Sheath Set	Kossel Medtech (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DYB	accessdata.fda.gov
October 15, 2026	K262214	Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)	Guangzhou Aimooe Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HAW	accessdata.fda.gov
October 15, 2026	K261616	Single-Use EBUS Balloon	Micro-Tech (Nanjing) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PSV	accessdata.fda.gov
October 14, 2026	K262885	308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)	Guangxi Hope Medical Devices Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FTC	accessdata.fda.gov
October 14, 2026	K262042	Sterilization Cassette (CASS-1)	Alliedstar Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	KCT	accessdata.fda.gov
October 14, 2026	K261169	Power Wheelchair (D39)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 14, 2026	K260264	Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)	Shanghai Medi Astro Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ETA	accessdata.fda.gov
October 13, 2026	K263257	Electrically Powered Wheelchair (YC-01)	Yurob Rehabilitation Medical Co., Ltd.	China	Substantially Equivalent	510(k) special	ITI	accessdata.fda.gov
October 13, 2026	K262652	Electric Wheelchair (CN501)	Zhejiang Shimo Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 13, 2026	K261572	Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)	Keyue (Hangzhou) Medical Information Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 13, 2026	K252288	TECAR Therapy Device (TC2000, TC2001)	Shenzhen Dongdixin Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PBX	accessdata.fda.gov
October 9, 2026	K262834	Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615...	Shenzhen Jianchao Intelligent Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
October 9, 2026	K262352	IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHT	accessdata.fda.gov
October 9, 2026	K260687	VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual...	Vivachek Biotech (Hangzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NBW	accessdata.fda.gov
October 8, 2026	K262346	CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight...	Wuhan Phomed Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 8, 2026	K261617	Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic...	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 7, 2026	K262822	Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)	Zhongshan GL Electronics Co. , Ltd.	China	Substantially Equivalent	510(k) traditional	BTA	accessdata.fda.gov
October 7, 2026	K261692	Diode Laser Hair Removal Machine (QDTM-03)	Beijing Nubway S&T Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 6, 2026	K261200	Power Wheelchair (D60)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 6, 2026	K261079	Power Wheelchair (DC12)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 5, 2026	K262812	Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1...	Sichuan Qianli-Beoka Medical Technology, Inc.	China	Substantially Equivalent	510(k) traditional	IRP	accessdata.fda.gov
October 5, 2026	K262285	UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)	Shijiazhuang Recovery Star Medical Device Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FTC	accessdata.fda.gov
October 2, 2026	K261741	Hemostatic Clip	Anrei Medical (Hz) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PKL	accessdata.fda.gov
October 2, 2026	K260490	Ninenovo Blood Oxygen Ring...	Shenzhen Ninenovo Technology Limited	China	Substantially Equivalent	510(k) traditional	DQA	accessdata.fda.gov
October 2, 2026	K260468	H100Plus Hemoglobin Testing System	Shenzhen Lifotronic Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PDJ	accessdata.fda.gov
October 1, 2026	K260470	Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C...	Shenzhen Brav Electronic Technologies Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
September 30, 2026	K263033	Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)	Fussen Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	OAS	accessdata.fda.gov
September 29, 2026	K262553	MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)	Zhejiang Kailang Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
September 29, 2026	K262241	Electric Wheelchair (0080)	Xuzhou Heabens Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 29, 2026	K262213	Power Mobility Scooter (MA03)	Nanjing Mijo Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
September 25, 2026	K254291	easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic...	Ezisurg Medical Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GDW	accessdata.fda.gov
September 24, 2026	K262183	Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)	Shenzhen Nuon Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
September 24, 2026	K261078	Electric Scooter (FNS01,FNS03)	Anhui Jbh Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
September 24, 2026	K260313	MD-6000S Bladder Scanner	MEDA Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IYO	accessdata.fda.gov
September 23, 2026	K262582	Electric wheelchair (GP100)	Suzhou Green Pine Medical Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 23, 2026	K262254	Hair Growth Comb (X-GC01)	Guangdong Ashmore Health Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
September 23, 2026	K261637	Single-use Flexible Bronchoscope	Hunan Vathin Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EOQ	accessdata.fda.gov
September 23, 2026	K254289	Portable Oxygen Concentrator (OX-1A-E, OX-1B)	Oxytek Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	CAW	accessdata.fda.gov
September 21, 2026	K262108	FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant...	Shanghai Personage Hygiene Products Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HIS	accessdata.fda.gov
September 21, 2026	K260512	Disposable Ureteral Access Sheath	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FED	accessdata.fda.gov
September 21, 2026	K260416	ZYLOX Hippo PTA Balloon Dilatation Catheter	Zylox Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LIT	accessdata.fda.gov
September 19, 2026	K261859	Electric Scooter (FDB08, FDB08A, FDB12)	Anhui JBH Medical Apparatus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	INI	accessdata.fda.gov
September 18, 2026	K262524	Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)	ONE BEAUTY Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OHT	accessdata.fda.gov
September 18, 2026	K261047	Dental Diode Laser Device (Laser-Pen)	Guilin Kevin Peter Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
September 18, 2026	K254179	Drainage Catheter	Canyon Medical, Inc.	China	Substantially Equivalent	510(k) traditional	FGE	accessdata.fda.gov
September 18, 2026	K254171	Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)	Shenzhen Mericonn Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	CAF	accessdata.fda.gov
September 17, 2026	K261817	Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)	Zhengzhou PZ Laser Slim Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
September 17, 2026	K261673	LED Therapy Device (QLXY-01)	Beijing Nubway S&T Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
September 17, 2026	K254203	Wearable Breast Pump (Model S36)	Shenzhen TPH Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
September 16, 2026	K262559	Mouth Guard	ChangSha ChuangDuoLe E-Commerce Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OBR	accessdata.fda.gov
September 16, 2026	K262054	Electric Wheelchair	Yongkang Joymax Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
September 16, 2026	K261919	Multifunctional wheelchair (YJ-059)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) traditional	IOR	accessdata.fda.gov
September 16, 2026	K261778	JADE SCORE PTA Scoring Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PNO	accessdata.fda.gov
September 16, 2026	K261370	LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))	Guangdong Newdermo Biotech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NFO	accessdata.fda.gov
September 16, 2026	K254212	NC PTA Balloon Dilatation Catheter	Kossel Medtech (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	LIT	accessdata.fda.gov
September 15, 2026	K260145	YJ-K1K2 Wheelchair (YJ-013F)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 15, 2026	K260144	Reclining wheelchair (YJ-013L)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 15, 2026	K260141	Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)	Zhenjiang Assure Medical Equipment Co., Ltd.	China	Substantially Equivalent	510(k) special	IOR	accessdata.fda.gov
September 14, 2026	K260795	Hand-held Dental X-ray System (HyperLight-M)	Changzhou Sifary Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EHD	accessdata.fda.gov
September 13, 2026	K262526	Safety lancet (XL)	Tianjin Huahong Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FMK	accessdata.fda.gov
September 11, 2026	K260410	Single Use Ureteral Access Sheath	Zhejiang Chuangxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	FED	accessdata.fda.gov
September 11, 2026	K254177	Disposable Sterile Skull Drill (LZ)	Guizhou Zirui Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HBF	accessdata.fda.gov
September 11, 2026	K254174	Surgical Power System	Guizhou Zirui Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	HBC	accessdata.fda.gov
September 11, 2026	K254119	Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder...	Shenzhen Xinyan Medical Technology Co.,ltd.	China	Substantially Equivalent	510(k) traditional	MWJ	accessdata.fda.gov
September 10, 2026	K262426	Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)	Wuhan Pioon Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Shanghai United Imaging Healthcare Co., Ltd.	26	October 28, 2026
Shenzhen TPH Technology Co., Ltd.	19	September 17, 2026
Shenzhen Kaiyan Medical Equipment Co., Ltd.	19	July 23, 2026
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	18	October 16, 2026
Shenzhen Ulike Smart Electronics Co., Ltd.	13	May 21, 2026
Shenzhen Root Innovation Technology Co., Ltd.	11	June 18, 2026
Unimed Medical Supplies, Inc.	11	June 5, 2026
Zhengzhou PZ Laser Slim Technology Co., Ltd.	9	September 17, 2026
Tianjin Huahong Technology Co., Ltd.	9	September 13, 2026
Promisemed Hangzhou Meditech Co., Ltd.	9	August 25, 2026
ZheJiang Decans Medical Devices Co., Ltd.	9	June 16, 2026
Changsha Anxiang Medical Technology Co., Ltd.	8	October 30, 2026
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	7	October 28, 2026
Beijing Nubway S&T Co., Ltd.	7	October 7, 2026
Hunan Vathin Medical Instrument Co., Ltd.	7	September 23, 2026
Joytech Healthcare Co. , Ltd.	7	August 13, 2026
Edan Instruments, Inc.	7	August 6, 2026
Aidite (Qinhuangdao) Technology Co., Ltd.	7	April 6, 2026
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	7	March 6, 2026
Hangzhou SHINING3D Dental Technology Co., Ltd.	6	October 30, 2026

By panel

Panel	Decisions	Latest
General, Plastic Surgery	249	October 28, 2026
Physical Medicine	175	October 30, 2026
Cardiovascular	115	October 28, 2026
Radiology	114	October 30, 2026
Gastroenterology, Urology	101	October 29, 2026
Obstetrics/Gynecology	82	September 21, 2026
Dental	72	October 30, 2026
General Hospital	41	October 30, 2026
Neurology	40	October 20, 2026
Anesthesiology	35	October 23, 2026
Orthopedic	24	October 29, 2026
Unknown	24	October 26, 2026
Ear, Nose, Throat	16	October 14, 2026
Clinical Chemistry	14	October 30, 2026
Clinical Toxicology	13	September 10, 2026
Microbiology	6	April 30, 2026
Ophthalmic	3	October 27, 2026
Medical Genetics	1	July 2, 2026
Pathology	1	December 28, 2024

By decision type

Decision type	Decisions	Latest
510(k) traditional	1,027	October 30, 2026
510(k) special	88	October 30, 2026
510(k) abbreviated	10	February 2, 2026
De Novo (dual track)	1	October 22, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.