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 2026-10-15, 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 386 of 3528

510(k) clearances, page 386 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K200710	Infrared PT2L Digital No-Touch Thermometer	Andon Health Co., Ltd	FLL	Class II	2020-10-01
K200544	SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+	DIAMOND DIAGNOSTICS Inc	CEM	Class II	2020-10-01
K200127	TELEGRAPH® EVOLUTION Humeral Nailing System	FH Industrie	HSB	Class II	2020-10-01
K200067	MectaScope System	Medacta International SA	HRX	Class II	2020-10-01
K202566	Wiygul Catheter	Big Blue Biotech, Inc.	EZD	Class II	2020-09-30
K202564	DigitalDiagnost C90	Philips Medical Systems DMC GmbH	MQB	Class II	2020-09-30
K202542	Allura Vaginal Stent	PMT Corp.	KXP	Class II	2020-09-30
K202376	EverLift Submucosal Lifting Agent	Gi Supply	PLL	Class II	2020-09-30
K201928	e-Ortho Shoulder Software	FH Industrie	LLZ	Class II	2020-09-30
K201188	Clear Guide SCENERGY	Clear Guide Medical	JAK	Class II	2020-09-30
K200475	IDS-iSYS Ostase BAP	Immunodiagnostic Systems Ltd.	CIN	Class II	2020-09-30
K192077	Tua Face Fitness / Tua Trend Face	Vupiesse S.R.L	NFO	Class II	2020-09-30
K192051	Thinq	Corticometrics, LLC	LLZ	Class II	2020-09-30
K202546	LVivo Seamless	Dia Imaging Analysis, Ltd.	QIH	Class II	2020-09-29
K201895	Cefaly Dual	Cefaly Technology	PCC	Class II	2020-09-29
K201819	Cadwell Apollo System	Cadwell Industries Inc	GWQ	Class II	2020-09-29
K201790	Dual Cure Resin Cement	Rizhao Huge Biomaterials Company, Ltd.	EMA	Class II	2020-09-29
K193401	Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants	Altatec GmbH	DZE	Class II	2020-09-29
K193131	BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle	Becton Dickinson & Co	BSP	Class II	2020-09-29
K191738	PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph	Philips North America LLC	DPS	Class II	2020-09-29
K202685	Eon Aligner	Eon Dental Jordan, LLC	NXC	Class II	2020-09-28
K202543	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip	Volcano Corporation	DQX	Class II	2020-09-28
K201814	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit	Becton Dickinson & Co	OYE	Class II	2020-09-28
K201795	Transcend	Ultradent Product, Inc.	EBF	Class II	2020-09-28
K201682	RIST Radial Access Catheter	Rist Neurovascular, Inc.	QJP	Class II	2020-09-28
K201221	Electrosurgical Generator	New Deantronics Taiwan Ltd.	GEI	Class II	2020-09-28
K200557	Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)	Jiangsu Shenli Medical Production Co., Ltd.	PNR	Class II	2020-09-28
K193299	VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)	bioMerieux, Inc.	LON	Class II	2020-09-28
K192717	da Vinci SP Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2020-09-28
K182906	Portable Mesh Nebulizer	Feellife Health Inc.	CAF	Class II	2020-09-27
K202567	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	Guangzhou Wondfo Biotech Co., Ltd.	NFT	Class II	2020-09-25
K202522	Synchro SELECT Guidewire	Stryker Corp.	MOF	Class II	2020-09-25
K202446	BD Preset Syringe & BD A-Line Syringe	Becton Dickinson & Co	JKA	Class II	2020-09-25
K202277	Surgical Face Mask	Jiangxi 3L Medical Products Group Co., Ltd	FXX	Class II	2020-09-25
K202039	Honorst Implant System	Medimecca Co Ltd	DZE	Class II	2020-09-25
K201820	NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System	Nu Vasive, Incorporated	MAX	Class II	2020-09-25
K201787	Light Cure Dental Adhesive	Rizhao Huge Biomaterials Company, Ltd.	KLE	Class II	2020-09-25
K201756	Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent	Stryker Sustainability Solutions	HIH	Class II	2020-09-25
K201439	Ventilator, Non-continuous (Respirator)	Respironics, Inc.	BZD	Class II	2020-09-25
K201273	ImageSPECTRUM	Canon, Inc.	NFJ	Class II	2020-09-25
K201103	Xeleris V Processing and Review Systems	GE Healthcare	LLZ	Class II	2020-09-25
K200076	Breezing Med	TF Health Corp.	BZL	Class II	2020-09-25
K200051	PUGGLE Enteral Feeding Pump and Feeding Set	Amsino International, Inc.	LZH	Class II	2020-09-25
K193583	Restrata®	Acera Surgical, Inc. C/O Linda Braddon, PhD	QSZ	Unclassified	2020-09-25
K193546	Distal Centralizers	Zimmer GmbH	JDG	Class II	2020-09-25
K191982	Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)	Shenzhen Kentro Medical Electronics Co., Ltd	NUH	Class II	2020-09-25
K202572	GXR-Series Diagnostic X-Ray System	DRGEM Corporation	KPR	Class II	2020-09-24
K202484	Cordera Hip System	ConforMIS, Inc.	LPH	Class II	2020-09-24
K202477	EndoGI S-Path Biliary Stent System	Endo GI Medical	FGE	Class II	2020-09-24
K201770	Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor	Masimo Corporation	DQA	Class II	2020-09-24