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 268 of 3528

510(k) clearances, page 268 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221684	Osstem Abutment System	OSSTEM Implant Co., Ltd.	NHA	Class II	2022-09-08
K221331	Disposable Endoscope Valves System	Changzhou Endoclean Medical Device Co., Ltd.	ODC	Class II	2022-09-08
K220595	NeoNavia Biopsy System	Neodynamics AB	KNW	Class II	2022-09-08
K220330	Soundly Anti Snoring Device	Greystone Ip, Ltd.	LRK	Class II	2022-09-08
K220143	BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens	Shenzhen Dashicheng Optical Technology Co., Ltd.	LPL	Class II	2022-09-08
K213989	Cranial EM System	Brainlab, Inc.	HAW	Class II	2022-09-08
K213947	Ultrasonic Endo Activation Device (Model:Actor I pro)	Changzhou Bomedent Medical Technology Co., Ltd	ELC	Class II	2022-09-08
K213267	Dynamis Pro Family	Fotona d.o.o.	GEX	Class II	2022-09-08
K211648	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	Diazyme Laboratories, Inc.	DFH	Class II	2022-09-08
K210973	MammaPrint FFPE NGS Kit	Agendia Inc	NYI	Class II	2022-09-08
K222111	Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G	Owen Mumford Limited	FMK	Class II	2022-09-07
K222110	Mariner RDX System	SeaSpine Orthopedics Corporation	NKB	Class II	2022-09-07
K222034	RightLance Blood Lancing System	Beijing Ruicheng Medical Supplies Co., Ltd.	QRL	Class II	2022-09-07
K221731	FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2022-09-07
K220920	Matreneu Percutaneous Balloon Compression Kit	Shenzhen Shineyard Medical Device Co., Ltd.	HAO	Class I	2022-09-07
K220783	syngo.via RT Image Suite	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2022-09-07
K220567	Easi-Vue embolic microspheres System	Abk Biomedical	KRD	Class II	2022-09-07
K220112	AXIOS Stent and Electrocautery-Enhanced Delivery System	Boston Scientific Corporation	PCU	Class II	2022-09-07
K203594	EyeCTester	Neuro-Eye Diagnostic Systems, LLC	QTW	Class I	2022-09-07
K222069	Ez3D-i/E3	Ewoosoft Co., Ltd	LLZ	Class II	2022-09-06
K222048	Spectrum IQ Infusion System with Dose IQ Safety Software	Baxter Healthcare Corporation	FRN	Class II	2022-09-06
K221929	Smith+Nephew INTELLIO Tablet	Smith+Nephew	ODA	Class II	2022-09-06
K221636	EMPHASYS Acetabular System	Depuy Ireland UC	LPH	Class II	2022-09-06
K221283	Hammertoe Truss System (HTS)	4Web Medical, Inc.	HTY	Class II	2022-09-06
K220962	ROTAPRO Rotational Atherectomy System	Boston Scientific Corporation	MCW	Class II	2022-09-06
K220251	Neodent Implant System - GM Narrow Implant System	JJGC Industria e Comercio de Materiais Dentarios SA	DZE	Class II	2022-09-06
K213960	LiverMultiScan v5 (LMSv5)	Perspectum Ltd.	LNH	Class II	2022-09-06
K213868	ASAHI Gladius Mongo18 PV ES	Asahi Intecc Co., Ltd.	DQX	Class II	2022-09-06
K211858	TULSA-PRO System	Profound Medical Inc.	PLP	Class II	2022-09-06
K222426	Perfetta Moderate Medical Face Mask	Phu Bao Group Company Limited	FXX	Class II	2022-09-02
K222075	CellFX System	Pulse Biosciences, Inc.	GEI	Class II	2022-09-02
K221957	Savewo ClassicMASK	Savewo Limited	FXX	Class II	2022-09-02
K221932	Omni Legend	GE Healthcare	KPS	Class II	2022-09-02
K221644	Synthetic Bone Putty	Ventris Medical	MQV	Class II	2022-09-02
K221557	Visera Hysterovideoscope Olympus HYF Type V	Olympus Medical Systems Corp.	HIH	Class II	2022-09-02
K221414	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	Silk Road Medical	LIT	Class II	2022-09-02
K221277	Mygen M-3004 RF Generator M-3004	RF Medical Co., Ltd	GEI	Class II	2022-09-02
K221085	LiNA OperaScope Needle	LiNA Medical Inc	FBK	Class II	2022-09-02
K213983	Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear	Yung Sheng Optical Co., Ltd.	LPL	Class II	2022-09-02
K213864	Bonebridge Osteosynthesis Plating System	Bonebridge AG	HRS	Class II	2022-09-02
K213855	Arrow Pressure Injectable Midline Catheter	Arrow International LLC (subsidiary of Teleflex Incorporated)	PND	Class II	2022-09-02
K213287	StageOne Knee Cement Spacer Molds	Zimmer GmbH	MBB	Class II	2022-09-02
K212222	Soniquence Reusable 3 Button Fingerswitch Wand	Soniquence, LLC	GEI	Class II	2022-09-02
K212189	FibroLux	Multi Radiance Medical	NHN	Class II	2022-09-02
K211178	DURAMESH Mesh Suture	Msi	GAW	Class II	2022-09-02
K203503	Camber Sacroiliac (SI) Fixation System	Camber Spine Technologies	OUR	Class II	2022-09-02
K221987	Erchonia GVL	Erchonia Corporation	NHN	Class II	2022-09-01
K221241	DrAid for Radiology v1	Vinbrain Joint Stock Company	QFM	Class II	2022-09-01
K221038	Disposable Medical Masks	Hantech Medical Device Co., Ltd.	FXX	Class II	2022-09-01
K220997	Wireless TENS/EMS, Bruno, Aela	Zmi Elecronics, Ltd.	NUH	Class II	2022-09-01