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 351 of 3528

510(k) clearances, page 351 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202578	KardiFlex NC Coronary Dilatation Catheter	Medcaptain Life Science Co., Ltd.	LOX	Class II	2021-05-06
K202031	Talent-Pro Electromagnetic Stimulator	Remed Co., Ltd.	IPF	Class II	2021-05-06
K201936	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL	Gilero, Inc	KPE	Class II	2021-05-06
K201697	Umbilical Vessels Catheter	Haolang Medical USA Corporation	FOS	Class II	2021-05-06
K211112	OIC External Fixation System	The Orthopaedic Implant Company	KTT	Class II	2021-05-05
K211008	Bose SoundControl Hearing Aids	Bose Corporation	QDD	Class II	2021-05-05
K210451	OrthoGold 100	Tissue Regeneration Technologies	ISA	Class I	2021-05-05
K210298	GR-14 Resin System	PRO3DURE Medical GmbH	EBI	Class II	2021-05-05
K203525	D function	Ito Co., Ltd.	NUW	Class II	2021-05-05
K200765	Genius / Genuin Total Knee System	Biorad Medisys Pvt. Ltd.	JWH	Class II	2021-05-05
K210682	SOTA Cloud Imaging	Sota Precision Optics, Inc. dba Sota Imaging	LLZ	Class II	2021-05-04
K210669	Quantum Mini Ventilation Module	Spectrum Medical Inc	DTX	Class II	2021-05-04
K210304	Surgical Mask	Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z.	FXX	Class II	2021-05-04
K203698	CoLink Sfx Implant System	In2bones USA, LLC	HTY	Class II	2021-05-04
K203655	Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)	Innovative Health, LLC.	NLH	Class II	2021-05-04
K203529	VASSALLO GT Hybrid	Filmecc Co., Ltd.	DQX	Class II	2021-05-04
K203450	EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)	Capnostics, LLC	EOX	Class II	2021-05-04
K203218	CaP Spheres Pellet Pack	Highridge Medical, LLC	MQV	Class II	2021-05-04
K203192	NaviCam Xpress Stomach System	Anx Robotica Corp.	QKZ	Class II	2021-05-04
K203135	Medline Vacu-line Suction Aspirator	MEDLINE INDUSTRIES, LP - Northfield	BTA	Class II	2021-05-04
K202921	Uro-G Cystoscope	Uroviu Corporation	FAJ	Class II	2021-05-04
K202521	PtoleMedic System	Lento Medical Innovation, Inc.	LLZ	Class II	2021-05-04
K201671	A-Link Z	Acuity Surgical Devices, LLC	OVD	Class II	2021-05-04
K201152	Electric Breast Pump	Guangdong Horigen Mother & Baby Products Co., Ltd.	HGX	Class II	2021-05-04
K200893	ProntoPump Sterile Tube Set	Ipax, Inc.	LHI	Class II	2021-05-04
K200768	Rebellion, Phantom Multi-Bite Kerrison Rongeur	Morpheus AG	HAE	Class II	2021-05-04
K210675	EasyWhip	Winter Innovations, Inc.	GAT	Class II	2021-05-03
K203749	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable	Ambu A/S	CBI	Class II	2021-05-03
K203710	Storz Medical MAGNETOLITH Muscle Stimulator	Storz Medical AG	IPF	Class II	2021-05-03
K203409	MC3 Crescent Jugular Dual Lumen Catheter	MC3, Inc.	PZS	Class II	2021-05-03
K202430	Kerecis Reconstruct	Kerecis Limited	OXH	Class II	2021-05-02
K201949	Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series	Nihon Kohden Corp.	KOI	Class II	2021-05-02
K211013	FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24	Inari Medical, Inc.	QEW	Class II	2021-04-30
K210993	CereLink ICP Monitor	Integra LifeSciences Production Corporation	GWM	Class II	2021-04-30
K210919	AcuityDRe	RadmediX, LLC	MQB	Class II	2021-04-30
K210647	SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter	Vascular Solutions LLC	DQY	Class II	2021-04-30
K210637	CD Horizon™ Spinal System	Medtronic, Inc.	NKB	Class II	2021-04-30
K210290	JACE Medical Thoracic Plating System	Jace Medical, LLC	HRS	Class II	2021-04-30
K210247	OsteoCentric Integrated Hip Fastener System	Osteocentric Technologies D.B.A. Osteocentric Trauma	JDO	Class II	2021-04-30
K210061	ProLift Lateral HELO Fixated	Life Spine	MAX	Class II	2021-04-30
K210001	HYPER AiR	Shanghai United Imaging Healthcare Co., Ltd.	KPS	Class II	2021-04-30
K203786	MAC 7 - Resting ECG Analysis System	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2021-04-30
K203699	syngo. CT Extended Functionalities	Siemens Medical Solutions USA, Inc.	JAK	Class II	2021-04-30
K203601	Innova Nasal Non-Vented Mask	SleepNet Corporation	BZD	Class II	2021-04-30
K203580	ArtiSential Laparoscopic Instruments-Electrodes	LivsMed Inc.	GEI	Class II	2021-04-30
K203267	The BioBrace Implant	Biorez, Inc.	OWW	Class II	2021-04-30
K203165	Disposable Ureteral Access Sheath	Suzhou Beyo Medical Technology Co., Ltd.	FED	Class II	2021-04-30
K210981	Pure Vu System	MOTUS GI Medical Technologies Ltd.	FDF	Class II	2021-04-29
K210944	Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)	Harbour Health, LLC	LZA	Class I	2021-04-29
K210605	3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation	3M Company	DWJ	Class II	2021-04-29