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 570 of 3529

510(k) clearances, page 570 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170378	AirLife Adult Heated Wire BiPAP/NIV Circuit	Jaeger Medical GmbH	BZE	Class II	2017-09-14
K170323	Entuit Start Initial Placement Gastrostomy Set	Cook Incorporated	KGC	Class II	2017-09-14
K170168	Masimo Rad-97 and Accessories	Masimo Corporation	MWI	Class II	2017-09-14
K163627	Shotel Ankle Arthrodesis Nail System	Biopro, Inc.	HSB	Class II	2017-09-14
K163556	MediClear PreOp	Covalontechnologies, Inc.	KKX	Class II	2017-09-14
K163209	Fiagon Navigation System	Fiagon GmbH	HAW	Class II	2017-09-14
K163148	BePOD® Foot Screws	Fournitures Hospitalieres Industrie	HWC	Class II	2017-09-14
DEN160018	reSet	Pear Therapeutics, Inc.	PWE	Class II	2017-09-14
K172142	FibroScan 430 Mini+	Echosens	IYO	Class II	2017-09-13
K171664	Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software	Bio-Rad Laboratories Inc.	GKA	Class II	2017-09-13
K171359	Pollogen Legend+ System	Pollogen Ltd	GEI	Class II	2017-09-13
K171201	NeuViz Prime Multi-slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2017-09-13
K171051	HORIZON Therapy System	Magstim Inc.	OBP	Class II	2017-09-13
K163215	AnemoCheck	Sanguina, Inc.	KHG	Class II	2017-09-13
K171770	cobas Cdiff Nucleic acid test for use on the cobas Liat System	Roche Molecular Systems Inc	OZN	Class II	2017-09-12
K171582	NEO Pedicle Screw System™	Neo Medical, Inc.	NKB	Class II	2017-09-12
K171537	CAPI 3 Hb A1c	Sebia, Inc.	PDJ	Class II	2017-09-12
K171233	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	IYN	Class II	2017-09-12
K171144	Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel	Medbio, LLC.	FMI	Class II	2017-09-12
K170875	da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2017-09-12
K170409	PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System	Topcon Medical Laser Systems, Inc. (Tmls)	GEX	Class II	2017-09-12
K170185	tremoFlo C-100 Airwave Oscillometry System	Thorasys Thoracic Medical Systems Inc.	PNV	Class II	2017-09-12
K172117	Prelude Pursuit Splittable Sheath Introducer	Merit Medical Systems, Inc.	DYB	Class II	2017-09-11
K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle	Care Fusion	KNW	Class II	2017-09-11
K171317	Clear Vinyl Powder-free Patient Examination Gloves	Shandong Zhi Hong Medical Products, Co., Ltd.	LYZ	Class I	2017-09-11
K171189	AIR-FLOW PLUS Prophylaxis powder	E.M.S. - Electro Medical Systems SA	EJR	Class I	2017-09-11
K171067	INVISION Total Ankle Revision System	Wrightmedicaltechnologyinc	HSN	Class II	2017-09-11
K170822	Electronic Caries Detector	Ortek Therapeutics, Inc.	NBL	Class II	2017-09-11
K170645	da Vinci Xi EndoWrist Instruments and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2017-09-11
K170644	da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)	Intuitive Surgical, Inc.	NAY	Class II	2017-09-11
K170596	TN-Brush	GENOSS Co., Ltd.	ELB	Class II	2017-09-11
K170487	Navina Classic System	Dentsply Sirona Inc	KNT	Class II	2017-09-11
K170368	Sterile NS System	Jeil Medical Corporation	GWO	Class II	2017-09-11
K170275	Tri Auto ZX2	J. Morita USA, Inc.	EKX	Class I	2017-09-11
K170047	All-in-One Health Monitor, PC-303	Shenzhen Creative Industry Co., Ltd	MWI	Class II	2017-09-09
K172170	APTUS(R) Wrist 2.5 System	Medartis AG	HRS	Class II	2017-09-08
K171893	Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)	Bluestone Synergy	MAX	Class II	2017-09-08
K171805	Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml	Conceptomed AS	FMF	Class II	2017-09-08
K171725	CuffLink Implant System	ConMed Corporation	MBI	Class II	2017-09-08
K171667	Powder Free Nitrile Examination Glove	Professional Latex Sdn Bhd	LZA	Class I	2017-09-08
K171648	Bm.iris	BLUECORE Company Co., Ltd.	GEX	Class II	2017-09-08
K171510	Footmotion Plating System	Newclip Technics	HRS	Class II	2017-09-08
K171351	Posterior Spine Truss System (PSTS) Interbody Fusion Device	4WEB Inc.	MAX	Class II	2017-09-08
K171334	Indego	Parker Hannifin Corp.	PHL	Class II	2017-09-08
K171330	Nanova Sealant	Nanova Biomaterials Inc	EBC	Class II	2017-09-08
K171251	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	Creagh Medical Ltd.	LIT	Class II	2017-09-08
K170854	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls	Instrumentation Laboratory Co.	LCO	Class II	2017-09-08
K170704	The Locking Pediatric Osteotomy Plate (LolliPOP) System	Orthopediatrics Canada ULC	KTT	Class II	2017-09-08
K170415	Medline Hemo-Force DVT Compression Sleeve	MEDLINE INDUSTRIES, LP - Northfield	JOW	Class II	2017-09-08
K170032	QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP	Fysicon BV	MWI	Class II	2017-09-08