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 612 of 3529

510(k) clearances, page 612 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162164	GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord	Sybron Dental Specialties, Inc.	MVL	Unclassified	2017-01-13
K161762	DynaMatrix/Dynamatrix Plus	Cook Biotech Incorporated	NPL	Class II	2017-01-13
K161328	Cantab Mobile	Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd.	PKQ	Class II	2017-01-13
K161106	Panpac Disposable Vacuum Curettes	Panpac Medical Corporation	HGH	Class II	2017-01-13
K160965	SuperLine	Dentium Co., Ltd.	DZE	Class II	2017-01-13
K153128	Kolplast Cervical Sample Collection Kit	Kolplast CI SA	HHT	Class II	2017-01-13
K163635	ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc. Ultrasound Group	IYN	Class II	2017-01-12
K163544	Lumipulse G Prolactin	Fujirebio Diagnostics, Inc.	JIT	Class II	2017-01-12
K163533	EzDent-i; E2; ProraView	Ewoosoft Co., Ltd	LLZ	Class II	2017-01-12
K163521	Lumipulse G LH Calibrators	Fujirebio Diagnostics, Inc.	JIT	Class II	2017-01-12
K163205	48CH Head Coil	GE Healthcare Coils (USA Instruments, Inc.)	MOS	Class II	2017-01-12
K163176	Exilis XP II	BTL Industries, Inc	PBX	Class II	2017-01-12
K162884	SpineGuard DSG Zavation Screw System	Spineguard, Inc.	HBG	Class II	2017-01-12
K162754	FREND Vitamin D Test System	Nanoentek USA, Inc.	MRG	Class II	2017-01-12
K162694	Ayers Rock Cervical interbody fusion system	Spineway	ODP	Class II	2017-01-12
K162532	WellDoc BlueStar, WellDoc BlueStar Rx	Welldoc	MRZ	Class II	2017-01-12
K162500	Ostial Sprit Cannulae	Spyder Medical	DWF	Class II	2017-01-12
K162336	Contour Next EZ Blood Glucose Monitoring System	Medrad, Inc.	NBW	Class II	2017-01-12
K162323	Tooth Shade Resin Material	Liaoning Upcera Co.,Ltd	EBF	Class II	2017-01-12
K162173	Elecsys CYFRA 21-1 CalCheck 5	Roche Diagnostics GmbH	JJX	Class I	2017-01-12
K161902	Meridian M110 Fetal Monitoring System	Mindchild Medical	HGM	Class II	2017-01-12
K161217	VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)	bioMerieux, Inc.	LON	Class II	2017-01-12
K163479	R2P Metacross RX	KANEKA Corporation	LIT	Class II	2017-01-11
K163128	Epic Pro	Biolase, Inc.	GEX	Class II	2017-01-11
K162885	SPY Phi Open Field Handheld Fluorescence Imaging System	Novadaq Technologies ULC	OWN	Class II	2017-01-11
K162810	InSeca ARC Stylus, Aerin Console	Aerin Medical, Inc.	GEI	Class II	2017-01-11
K162765	Venus Velocity Diode Laser System	Venus Concept Inc.	GEX	Class II	2017-01-11
K162387	U-IGNITE Bladeless Trocar	Tianjin Uwell Medical Device Manufacturing Co Ltd	GCJ	Class II	2017-01-11
K162261	Ceramage Up	Shofu Dental Corp.	EBF	Class II	2017-01-11
K162201	Desara TV, Desara Blue TV	Caldera Medical, Inc.	OTN	Class II	2017-01-11
K162057	ConceptoMed Luer-Jack Slip 10ml	Conceptomed AS	FMF	Class II	2017-01-11
K161517	Mortara Surveyor Patient Monitor	Mortara Instrument, Inc.	MHX	Class II	2017-01-11
K161281	Dentalis Bio Solution Implants	Dentalis Bio Solution Implants, LLC	DZE	Class II	2017-01-11
K161204	ENDOCAM Flex HD Camera System 5521	Richard Wolf Medical Instruments Corp.	FET	Class II	2017-01-11
K160178	Lympha-Flow(LF1200)	Daesung Maref Co.,Ltd	IRP	Class II	2017-01-11
K163252	Mammomat Fusion with Stereotactic Biopsy	Siemens Medical Solutions USA, Inc.	MUE	Class II	2017-01-10
K163120	EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2017-01-10
K163015	Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak	Bio-Rad Laboratories Inc.	JJY	Class I	2017-01-10
K162805	Akros Fibulink Syndesmosis Repair Kit	Akros Medical	HTN	Class II	2017-01-10
K162179	osteo-WEDGE II ® Open Wedge Bone Locking Plate System	Graham Medical Technologies, L.L.C. d.b.a. GraMedica	HRS	Class II	2017-01-10
K160991	Neo GBR System	Neobiotech Co., Ltd.	DZL	Class II	2017-01-10
K162819	Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs	Hartalega Sdn Bhd	LZA	Class I	2017-01-09
K162818	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)	Hartalega Sdn Bhd	LZA	Class I	2017-01-09
K162767	Sentinel BreastScan II System	First Sense Medical, LLC	LHQ	Class I	2017-01-09
K162483	Symbia Intevo Bold	Siemens Medical Solutions USA, Inc.	KPS	Class II	2017-01-09
K162208	DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent	Siemens Healthcare Diagnostics Inc.	CFN	Class II	2017-01-09
K162083	RII Multi-function Infrared Thermometer, Model TH52Z	Radiant Innovation Inc.	FLL	Class II	2017-01-09
K161971	Bindex BI-2	Bone Index Finland Ltd.	MUA	Class II	2017-01-09
K161841	D2p	3D Systems, Inc.	LLZ	Class II	2017-01-09
K161508	Ceruloplasmin	Beckman Coulter Ireland Inc	DDB	Class II	2017-01-09