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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 563 of 3529

510(k) clearances, page 563 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173063	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System	Acist Medical Systems, Inc.	OBJ	Class II	2017-10-23
K172805	gi-4000 Electrosurgical Generator	United States Endoscopy Group, Inc.	GEI	Class II	2017-10-23
K172585	Liberty Anterior Cervical Plate	Valorus Spine, LLC	KWQ	Class II	2017-10-23
K172546	AnyPlus® Spinal Fixation System	GS Medical Co., Ltd.	NKB	Class II	2017-10-23
K172542	Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.	Liofilchem S.r.l.	JWY	Class II	2017-10-23
K172343	Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MAX	Class II	2017-10-23
K172282	Panther Fusion Paraflu Assay	Hologic, Inc.	OOU	Class II	2017-10-23
K172254	Lyme B. burgdorferi (IgM) MarStripe Test	Trinity Biotech, PLC	LSR	Class II	2017-10-23
K172213	MECRON Cannulated Screw System	Merete GmbH	HWC	Class II	2017-10-23
K171996	TruWave Disposable Pressure Transducer	Edwards Lifesciences LLC	DXO	Class II	2017-10-23
K171938	KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set	Medtronic, Inc.	PML	Class II	2017-10-23
K171647	BeneLife Premium Facial Treatment Pack, Model: QZ0701A	Infinitus (China) Company, Ltd.	NFO	Class II	2017-10-23
K171640	M-ARS ACL: Anatomic Ribbon Surgery System	Medacta International SA	MBI	Class II	2017-10-23
K171489	Acapella Cervical Spacer System	Choicespine, LP	OVE	Class II	2017-10-23
K171293	G3™ Active Plate® Miniature System	Genesis Fracture Care, Inc.	HRS	Class II	2017-10-23
K171277	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Innovative Health, LLC.	DRF	Class II	2017-10-23
K171001	Monosyn Quick Synthetic Absorbable Surgical Suture	Aesculap Inc	GAM	Class II	2017-10-23
K170612	STERILE VINYL EXAMINATION GLOVES, Powder Free	Primus Gloves Pvt Limited	LYZ	Class I	2017-10-23
K170317	Alinity i Total ß-hCG Reagent Kit, Alinity i System	Abbott Medical	DHA	Class II	2017-10-23
K170056	IRENE Cannulated Screw System	Tianjin Zhengtian Medical Instrument Co., Ltd.	HWC	Class II	2017-10-23
K173052	Heraeus TMW Guidewire	Heraeus Medical Components, LLC	DQX	Class II	2017-10-20
K172881	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2017-10-20
K172869	Discovery XR656 HD	GE Hualun Medical Systems Co., Ltd.	KPR	Class II	2017-10-20
K172403	GSI Novus	Grason-Stadler, Inc.	EWO	Class II	2017-10-20
K172352	TREFOIL System	Nobel Biocare AB	DZE	Class II	2017-10-20
K172149	FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture	M/s. Meril Endo Surgery Private Limited.	GAP	Class II	2017-10-20
K172090	GuideLiner V3 Catheter	Vascular Solutions LLC	DQY	Class II	2017-10-20
K172027	Adani MammoScan	Adani	MUE	Class II	2017-10-20
K171987	Finessis Zero Flexylon Powder Free Sterile White Surgical Glove	Lucenxia Prescience AG	KGO	Class I	2017-10-20
K171709	BR-FHUS Viewer 1.0	Taihao Medical, Inc.	LLZ	Class II	2017-10-20
K171594	Accuro	Rivanna Medical, Inc	IYO	Class II	2017-10-20
K171257	ClearPoint System	Mri Interventions, Inc.	ORR	Class II	2017-10-20
K171206	D'Vill Introducer	Numed Inc	DYB	Class II	2017-10-20
K171052	Ultimate Contour, Ultimate Contour Mini	Cao Group, Inc.	PBX	Class II	2017-10-20
K170671	SafeSept Transseptal Guidewire	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2017-10-20
K170371	DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe	Intervene Group Limited	PNR	Class II	2017-10-20
K170150	Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags	S.A.L.F. SpA	KDL	Class II	2017-10-20
K170106	MyKnee PPS-Pin Positioners	Medacta International SA	JWH	Class II	2017-10-20
K163713	Sofia Lyme FIA, Sofia Lyme Control Set	Ortho-Clinical Diagnostics, Inc.	LSR	Class II	2017-10-20
K163623	Quantra	Hologic, Inc.	LLZ	Class II	2017-10-20
K162662	GingiDent Gingival Retraction Paste	Pac-Dent International, Inc.	MVL	Unclassified	2017-10-20
K160405	Octavius I, Octavius II, Octavius III, Octavius 4D	Ptw-Freiburg Physikalisch-Technische-Werkstaetten	IYE	Class II	2017-10-20
K172811	EsophyX Z, EsophyX2 HD	Endogastric Solutions, Inc.	ODE	Class II	2017-10-19
K172527	Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe	Cook Incorporated	LJE	Unclassified	2017-10-19
K172376	Discovery Pico, Discovery Pico Plus	Quanta System Inc.	GEX	Class II	2017-10-19
K172281	PuRE PMMA Disc	Quest Dental USA Corp	EBG	Class II	2017-10-19
K172079	Avail	Omron Healthcare Co., Ltd.	NUH	Class II	2017-10-19
K171774	RPM Reinforced PTFE Mesh	Osteogenics Biomedical, Inc.	NPK	Class II	2017-10-19
K171672	065 Zenith, 074 Zenith	Inneuroco, Inc.	DQY	Class II	2017-10-19
K171243	audifon Tinnitus-Module	Audiofon USA, Inc.	KLW	Class II	2017-10-19