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 193 of 3528

510(k) clearances, page 193 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K233258	Shadow Knotless All-Suture Anchors	Responsive Arthroscopy	MBI	Class II	2023-10-23
K232561	Ripley Spinal Screw System by SAGICO	Sagico VA USA, LLC	NKB	Class II	2023-10-23
K232305	AI-Rad Companion Brain MR	Siemens Medical Solutions USA, Inc.	QIH	Class II	2023-10-23
K232205	Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set	Vesco Medical LLC	LZH	Class II	2023-10-23
K232201	VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin	bioMerieux, Inc.	LON	Class II	2023-10-23
K232143	Applanation Tonometer HT-5000	Huvitz Co., Ltd.	HKY	Class II	2023-10-23
K231764	Ultrasound System 1300	BK Medical ApS	IYN	Class II	2023-10-23
K231732	CleanSeal Advanced Bipolar Vessel Sealer Maryland	ConMed Corporation	GEI	Class II	2023-10-23
K231560	MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2023-10-23
K230893	Swiss LthoClast Trilogy	E.M.S. - Electro Medical Systems SA	FEO	Class II	2023-10-23
K230281	Picoclamp	Kono Seisakusho	DXC	Class II	2023-10-23
K232091	JO Coconut Hybrid Cooling Personal Lubricant	CC Wellness LLC	NUC	Class II	2023-10-22
K231539	pRESET LITE Thrombectomy Device	Phenox Inc	POL	Class II	2023-10-21
K233065	V-PRO maX 2 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2023-10-20
K232951	BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)	STERIS Corporation	ODC	Class II	2023-10-20
K232922	Pure-Vu EVS System	MOTUS GI Medical Technologies Ltd.	FDF	Class II	2023-10-20
K232552	TuxDeluxe (Size 1 6100B, Size 2 6101B)	Tuxedo Imaging	MUH	Class II	2023-10-20
K232550	Nitrile Examination Gloves, Dual Color Black-Blue	Shanxi Hongjin Plastic Technology Co., Ltd	LZA	Class I	2023-10-20
K232236	Echo	Quanta System Inc.	GEX	Class II	2023-10-20
K232042	NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);	MediConcepts Technology (Shenzhen) Company Limited	GCJ	Class II	2023-10-20
K231902	GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)	Ansell Healthcare Products LLC	KGO	Class I	2023-10-20
K231809	Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement	ulrich medical USA Inc	PML	Class II	2023-10-20
K231578	Lucitone Digital Print Denture System	Dentsply Sirona Inc	EBI	Class II	2023-10-20
K231388	NextDent Base	Vertex-Dental B.V.	EBI	Class II	2023-10-20
K230998	Digital Wireless Intraoral X-Ray Sensor	iRay Imaging Technology (Haining) Limited	MUH	Class II	2023-10-20
K230983	Unicare (K-UNICARE-USA)	Tenscare Ltd.	KPI	Class II	2023-10-20
K230209	Sonix Health	Ontact Health Co., Ltd.	QIH	Class II	2023-10-20
K223909	R2GATE Lite TM	Megagen Implant Co., Ltd.	LLZ	Class II	2023-10-20
K223557	SPECTRALIS HRA+OCT and variants	Heidelberg Engineering GmbH	OBO	Class II	2023-10-20
K232910	CombiDiagnost R90	Philips Medical Systems DMC GmbH	JAA	Class II	2023-10-19
K232905	Medline UNITE® REFLEX® Nitinol Staple Kit	MEDLINE INDUSTRIES, LP - Northfield	JDR	Class II	2023-10-19
K232484	KeyLift™ Expandable Interlaminar Stabilization System	Amplio Spine	PEK	Class II	2023-10-19
K232371	Actinia® hip stems	implantcast GmbH	LZO	Class II	2023-10-19
K231976	StealthStation Cranial Software, v3.1.5 (9735585)	Medtronic Navigation, Inc	HAW	Class II	2023-10-19
K231749	Radio Frequency System	Shenzhenshi Sincoheren S&T Development Co., Ltd.	GEI	Class II	2023-10-19
K231704	Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System	Life Spine	OVE	Class II	2023-10-19
K231664	IRRAflow Active Fluid Exchange System (AFES)	Irras USA, Inc.	JXG	Class II	2023-10-19
K231381	Xpert Xpress MVP; GeneXpert Xpress System	Cepheid	PQA	Class II	2023-10-19
K230478	Acro Composites Interbody System	Acro Composites, LLC	ODP	Class II	2023-10-19
K230476	Oran Park Mask	Resmed Pty Ltd (Registration Number: 3004604967)	BZD	Class II	2023-10-19
K230459	C.C. Life 21	21 Equipment S.r.l.	NFO	Class II	2023-10-19
K230178	EasyOne Sky Spirometer	NDD Medizintechnik AG	BZG	Class II	2023-10-19
K232924	T-Line® Hernia Mesh	Deep Blue Medical Advances, Inc.	FTL	Class II	2023-10-18
K232897	Arthrex Small External Fixation System	Arthrex GmbH	KTT	Class II	2023-10-18
K232524	Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set	Perfuze	NRY	Class II	2023-10-18
K232123	MectaLIF Anterior Lag Extension	Medacta International SA	OVD	Class II	2023-10-18
K231907	Medline Safety Insulin and TB Syringes	MEDLINE INDUSTRIES, LP - Northfield	MEG	Class II	2023-10-18
K231826	Omnipod 5 ACE Pump	Insulet Corporation	QFG	Class II	2023-10-18
K231824	SmartBolus Calculator	Insulet Corporation	QRX	Class II	2023-10-18
K231781	OptiMesh Multiplanar Expandable Interbody Fusion System	Spineology, Inc.	OQB	Class II	2023-10-18