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 611 of 3529

510(k) clearances, page 611 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163605	Ledex Wl070+	Dentmate Technology Co., Ltd.	EBZ	Class II	2017-01-19
K163113	Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2017-01-19
K163069	Olympus Small Intestinal Capsule Endoscope System	Olympus Medical Systems Corp.	NEZ	Class II	2017-01-19
K162932	Ranfac Fat Aspiration Cannula	Ranfac Corp.	MUU	Class II	2017-01-19
K162764	Jazz Frame System	Implanet	NKB	Class II	2017-01-19
K162472	TrueBeam-TrueBeam STx-Edge	Varian Medical Systems, Inc.	IYE	Class II	2017-01-19
K162434	NC Gallant PTCA Catheter	Medinol Ltd.	LOX	Class II	2017-01-19
K162430	UniStrip1 Generic Blood Glucose Test Strips	OK Biotech Co., Ltd.	NBW	Class II	2017-01-19
K162399	Atellica CH Magnesium (Mg)	Siemens Healthcare Diagnostics Inc.	JGJ	Class I	2017-01-19
K162397	Titan 3 Low Speed Angle Attachments	Dentalez, Inc.	EGS	Class I	2017-01-19
K162242	Comfort Flo Humidification System	Teleflexmedical, Inc.	BTT	Class II	2017-01-19
K162137	Fever Scout™ Continuous Monitoring thermometer	Vivalnk, Inc.	FLL	Class II	2017-01-19
K161650	Polysmith Sleep System, Model NTI7593	Neurotronics, LLC	OLV	Class II	2017-01-19
K161593	GMI Frontier Dental Implant System	Ilerimplant S.L	DZE	Class II	2017-01-19
K161492	Juno VPAP ST-A	ResMed Corp	MNS	Class II	2017-01-19
K161418	Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set	Cardinalhealth	OMP	Class II	2017-01-19
K161414	Anatomic Total Knee System	Amplitude	JWH	Class II	2017-01-19
K161255	meso-relle (AAL34, AAL36, AM30G)	Biotekne SRL	FMI	Class II	2017-01-19
K161178	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2017-01-19
K161090	Cranial PSI	Ossdsign	GXN	Class II	2017-01-19
K160660	Medline Waste Station	MEDLINE INDUSTRIES, LP - Northfield	DQO	Class II	2017-01-19
K160589	Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe	Certa Dose	PQX	Class II	2017-01-19
K163657	Quantum Workstation	Spectrum Medical Inc	DRY	Class II	2017-01-18
K163310	NovaBone IRM	Novabone Products, LLC	MQV	Class II	2017-01-18
K163254	Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2017-01-18
K163156	SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides	Materialise N.V.	PBF	Class II	2017-01-18
K162895	Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5	Roche Diagnostics GmbH	MMI	Class II	2017-01-18
K162817	Noddle(TM)	Iowa Adaptive Technologies, Inc. dba Voxello, Inc.	ILQ	Class II	2017-01-18
K162651	Breast BI 7 MR Coil Mammavention 3T	Moras Mri Products GmbH	MOS	Class II	2017-01-18
K162432	Multi-Link X2 ECG Cable and Lead Wire System	Medtronic, Inc.	DSA	Class II	2017-01-18
K162197	EndoClot	Endoclot Plus Co., Ltd.	GCJ	Class II	2017-01-18
K162121	Siconus SI Joint Fixation System	Camber Spine Technologies	OUR	Class II	2017-01-18
K161904	GEO Bone Screw System	Gramercy Extremity Orthopeidics, LLC	HWC	Class II	2017-01-18
K161412	F&P Brevida™ Nasal Pillows Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2017-01-18
K161274	Bondiloxs Topical Hemostatic Granules	Medtrade Products Ltd.	QSY	Unclassified	2017-01-18
K161091	STIMPOD NMS460 Nerve Stimulator	Xavant Technology (Pty) Ltd	GZJ	Class II	2017-01-18
K153587	Taps for Resorbable Screws	Synthes (USA) Products LLC	HBG	Class II	2017-01-18
K163554	hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test	Immunostics, Inc.	KHE	Class II	2017-01-17
K163231	Chameleon PTA Balloon Catheter	Av Medical Technologies, Ltd.	LIT	Class II	2017-01-17
K162663	WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A	Well-Life Healthcare Limited	GZJ	Class II	2017-01-17
K162455	Humelock Reversed Shoulder	Fx Shoulder Solutions SAS	PHX	Class II	2017-01-17
K161514	Precision Thin Reciprocating Blade, 0.010in.	Stryker Corp.	EQJ	Class I	2017-01-17
K163546	Lumipulse G Progesterone-N Calibrators	Fujirebio Diagnostics, Inc.	JIT	Class II	2017-01-13
K163541	Magseed Magnetic Marker System	Endomagnetics Ltd	PBY	Class II	2017-01-13
K163534	Lumipulse G FSH-N Calibrators	Fujirebio Diagnostics, Inc.	JIT	Class II	2017-01-13
K163519	Rx Dc	Cefla S.C.	EHD	Class II	2017-01-13
K162864	OsteoVation Impact	Skeletal Kinetics, LLC	GXP	Class II	2017-01-13
K162775	Legion Cone System	Smith & Nephew, Inc.	JWH	Class II	2017-01-13
K162511	LELO RESPECT HEX Natural Rubber Latex Condom	Lelo, Inc.	HIS	Class II	2017-01-13
K162489	RED Light Device	Zhongshan Bisen Plastic Electronic Products Co.,Ltd	OHS	Class II	2017-01-13