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 624 of 3529

510(k) clearances, page 624 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162095	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2016-11-02
K161670	Lucid Q-PTP / HWA 55	Bison Medical Co., Ltd	GEX	Class II	2016-11-02
K161378	joimax Electrosurgical Instruments	Joimax GmbH	GEI	Class II	2016-11-02
K161370	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	GXQ	Class II	2016-11-02
K160746	CARDIOLINE touchECG	Cardioline S.p.A.	DPS	Class II	2016-11-02
K160561	Boosting Catheter	Qxmedical, LLC	DQY	Class II	2016-11-02
K160421	Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter	Innovative Health, LLC.	NLH	Class II	2016-11-02
K162453	13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)	Pan Medical, Ltd.	NDN	Class II	2016-11-01
K162358	T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System	Synthes (USA) Products LLC	MAX	Class II	2016-11-01
K162155	Xario 200 Diagnostic Ultrasound System V5.0	Toshibamedical Systems Corporation	IYN	Class II	2016-11-01
K162062	AVAmax Vertebral Balloon, AVAflex Vertebral Balloon	Stryker Corp.	HRX	Class II	2016-11-01
K162002	Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay	Zdi, Solutions, LLC	IYE	Class II	2016-11-01
K161974	SLENDERTONE® Connect Abs, Type 570	Bio-Medical Research, Ltd.	NGX	Class II	2016-11-01
K161620	Anatomical Shoulder Domelock Dome centric	Zimmer GmbH	HSD	Class II	2016-11-01
K161454	Propeller Sensor Model 2015-E	Reciprocal Labs Corporation	CAF	Class II	2016-11-01
K160895	Initia Total Hip System & BIOCERAM AZUL(R) HEAD	KYOCERA Medical Corporation	LZO	Class II	2016-11-01
K162777	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	QEY	Class II	2016-10-31
K162741	AxoGuard Nerve Connector	Cook Biotech Incorporated	JXI	Class II	2016-10-31
K162150	BreathID Hp Lab System	Meridian Bioscience Israel Ltd.	MSQ	Class I	2016-10-31
K161851	Glass Ionomer Cement (Luting)	Shandong Huge Dental Material Corporation	EMA	Class II	2016-10-31
K161483	Unger Quad Injector	Gyn-Disposables, Inc.	LCJ	Unclassified	2016-10-31
K161448	Footmotion Plating System	Newclip Technics	HRS	Class II	2016-10-31
K160450	Pleurx Pleural Catheter System	Care Fusion	DWM	Class II	2016-10-31
K160141	miraDry System	miraDry, Inc.	NEY	Class II	2016-10-31
K152472	Disposable Pressure Transducer	Zhejiang Haisheng Medical Device Co., Ltd.	DRS	Class II	2016-10-31
K161282	FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W	Medico Electrodes International Ltd	GXY	Class II	2016-10-30
K162715	SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene	SeaSpine Orthopedics Corporation	MAX	Class II	2016-10-28
K162513	Arterys Software v2.0	Arterys Inc.	LLZ	Class II	2016-10-28
K162437	Codman EDS3 CSF External Drainage System	Cerenovus, Inc.	JXG	Class II	2016-10-28
K162422	Klassic Knee System	Total Joint Orthopedics, Inc.	JWH	Class II	2016-10-28
K162419	FIREFLY® Pedicle Screw Navigation Guide	Mighty Oak Medical	PQC	Class II	2016-10-28
K161725	Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail	Medela AG	HGX	Class II	2016-10-28
K161520	ELEOS Limb Salvage System	Onkos Surgical, Inc.	KRO	Class II	2016-10-28
K161497	Dental Implants and Abutments	Ditron Precision, Ltd.	DZE	Class II	2016-10-28
K160974	Gammex Cut-Resistant Glove Liner	Ansell Healthcare Products LLC	KGO	Class I	2016-10-28
K160882	PaX-i3D Green Premium (Model: PCT-90LH)	Vatech Co., Ltd.	OAS	Class II	2016-10-28
K160519	Link Abutment for CEREC	OSSTEM Implant Co., Ltd.	NHA	Class II	2016-10-28
K160488	Cutera enlighten III Laser System	Cutera Inc	GEX	Class II	2016-10-28
K160312	Fraxis Duo	Ilooda Co,., Ltd.	GEX	Class II	2016-10-28
K160297	Tuohy NRFit	Pajunk GmbH Medizintechnologie	BSP	Class II	2016-10-28
K160143	ClearVision ExamVue Flat Panel Detector	JPI Healthcare Co., Ltd	MQB	Class II	2016-10-28
K152533	Xonrid Gel	Helsinn Healthcare SA	FRO	Unclassified	2016-10-28
DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	Geneohm Sciences Canada, Inc. (BD Diagnostics)	PQA	Class II	2016-10-28
K162750	Libra Pedicle Screw System	Spinal Balance, Inc.	NKB	Class II	2016-10-27
K162367	Erisma® LP MIS	Clariance-SAS	NKB	Class II	2016-10-27
K162256	Klassic Femur, Porous, Klassic Tibial Baseplate, Porous	Total Joint Orthopedics, Inc.	MBH	Class II	2016-10-27
K162169	EdgeOne CO2 Laser	Jeisys Medical Inc.	GEX	Class II	2016-10-27
K161822	Torcon NB Advantage Catheters	Cook Incorporated	DQO	Class II	2016-10-27
K161718	MaxBlend 2, MaxBlend Lite	Maxtec, LLC	BZR	Class II	2016-10-27
K161605	Smart External Drain (SED) System	Aqueduct Critical Care, Inc.	JXG	Class II	2016-10-27