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 2026-10-15, 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 308 of 3528

510(k) clearances, page 308 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212842	Microvolume Luer Access Device	B.Braun Medical, Inc.	FPA	Class II	2022-01-18
K212713	Air compression leg massager HY-1117A	Xiamen High Top Electronic Technology Co.,Ltd.	IRP	Class II	2022-01-18
K212503	HP458E Electrically Powered Wheelchair	Kunshan Hi-Fortune Health Products Co., Ltd.	ITI	Class II	2022-01-18
K210679	Medical Face Mask	Wuxi Yushou Medical Appliances Co., Ltd	FXX	Class II	2022-01-18
K201044	CHIRANA Insulin Syringes	Chirana T. Injecta	FMF	Class II	2022-01-18
K212994	Medical Face Mask	Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.	FXX	Class II	2022-01-17
K213920	Kangbeier Surgical Mask (Model: KBR-1001)	Xinxiang Kangbeier Medical Technology Co., Ltd.	FXX	Class II	2022-01-16
K211980	SIGNA Prime	GE Healthcare (Tianjin) Company Limited	LNH	Class II	2022-01-16
K211833	Disposable Medical Face Mask	Zhejiang the Purples Protective Products Co.,Ltd	FXX	Class II	2022-01-16
K212772	Precision Align	Precision Align, LLC	NXC	Class II	2022-01-15
K211360	Disposable Nitrile Powder Free Examination Gloves (Non-sterile)	PT. Universal Gloves	LZA	Class I	2022-01-15
K213927	Respiratory Gating for Scanners v2.0	Varian Medical Systems, Inc.	JAK	Class II	2022-01-14
K213833	SCOPE BUDDY PLUS Endoscope Flushing Aid	Medivators Inc	FEB	Class II	2022-01-14
K213737	Quantib ND	Quantib B.V.	LLZ	Class II	2022-01-14
K213643	UltraPrint-Dental Temp C&B UV	Guangzhou Heygears IMC., Inc.	EBG	Class II	2022-01-14
K213602	Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit	Medtronic, Inc.	FJS	Class II	2022-01-14
K213593	OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD	Boston Scientific Corporation	OBJ	Class II	2022-01-14
K213335	Capsule Surveillance System	Capsule Surveillance Technologies, SAS /Capsule Tech, Inc.	MWI	Class II	2022-01-14
K213307	Eclipse II with Smart Noise Cancellation	Eastman Kodak Company	MQB	Class II	2022-01-14
K213033	iASSIST Knee System	Orthosoft D/B/A Zimmer Cas	OLO	Class II	2022-01-14
K212997	Surgical Mask	Guangdong Zhizhen Biological Medical Co., Ltd.	FXX	Class II	2022-01-14
K212913	Surgical Face Mask	Jiangxi Ganlong Pharmaceutical Co., Ltd.	FXX	Class II	2022-01-14
K212478	Dermatological diode laser system	Beijing Stelle Laser Technology Co., Ltd.	GEX	Class II	2022-01-14
K212318	IPL Hair Removal	Dongguan Define Beauty Electronic Technology Co.,Ltd	OHT	Class II	2022-01-14
K212093	Medline Universal Grounding Pad	MEDLINE INDUSTRIES, LP - Northfield	GEI	Class II	2022-01-14
K211814	Wellead Endoscopic Seal	Well Lead Medical Co. Ltd	ODC	Class II	2022-01-14
K211632	Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)	Shenzhen Narig Bio-Medical Technology Co., Ltd.	DQA	Class II	2022-01-14
K211254	ARAI Surgical Navigation System	Surgalign Spine Technologies	SBF	Class II	2022-01-14
K210760	Precise Image	Philips Medical Systems Nederland B.V.	JAK	Class II	2022-01-14
K210466	Silver Gelling Fiber Dressing	Winner Medical Co., Ltd.	FRO	Unclassified	2022-01-14
K203773	BRM TOOL Screws	BRM Extremities SRL	HWC	Class II	2022-01-14
K202783	Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing	Smith & Nephew Medical Ltd	OMP	Class II	2022-01-14
K201057	Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	QHW	Class II	2022-01-14
K220097	PRESIDENT The Original	Coltene /Whaledent AG	ELW	Class II	2022-01-13
K213895	Distal Humerus Plating System	Skeletal Dynamics, Inc	HRS	Class II	2022-01-13
K213859	Stronghold Group Nitrile Examination Glove, Powder Free	Stronghold Group, LLC	LZA	Class I	2022-01-13
K213642	Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert	GE Healthcare	IYN	Class II	2022-01-13
K211361	3N Contact Lenses Adjunct Cleaner	Suzhou 3N Biological Technology Co., Ltd.	LYL	Class II	2022-01-13
K203706	Dental Electric Motor	Guilin Woodpecker Medical Instrument Co., Ltd	EBW	Class I	2022-01-13
K214012	Straight Arm DDR	Konica Minolta, Inc.	KPR	Class II	2022-01-12
K213915	BIB Stent Placement Catheter	Numed Inc	NVM	Class II	2022-01-12
K213308	Venus BlissMAX	Venus Concept USA Inc.	PBX	Class II	2022-01-12
K213095	andorate Suction Valve, andorate Air/Water Valve	GA Health Company Limited	ODC	Class II	2022-01-12
K212877	Arm Blood Pressure Monitor	Alicn Medical Shenzhen, Inc	DXN	Class II	2022-01-12
K212718	Surgical gowns	Xiantao Dingcheng Non-Woven Product Co., Ltd.	FYA	Class II	2022-01-12
K212569	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	Materialise N.V.	QHE	Class II	2022-01-12
K212005	UNiD Spine Analyzer	Medicrea International	LLZ	Class II	2022-01-12
K213942	Esteya	Nucletron BV	JAD	Class II	2022-01-11
K213391	High Retention Attachment System	Zest Anchors LLC	NHA	Class II	2022-01-11
K213380	360Cas	Kico Knee Innovation Company	OLO	Class II	2022-01-11