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 2026-10-19, 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 482 of 3529

510(k) clearances, page 482 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K183222	MAGNETOM Terra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2019-02-15
K183217	IPL Hair Removal Device	Touchbeauty Beauty & Health (Shenzhen) Co., Ltd	OHT	Class II	2019-02-15
K183209	3M Comply Hydrogen Peroxide Indicator Tape	3M Company	JOJ	Class II	2019-02-15
K183072	EndoFLIP System	Crospon, Ltd.	FFX	Class II	2019-02-15
K183049	Reliance Lumbar IBF System	Reliance Medical Systems, LLC	MAX	Class II	2019-02-15
K183039	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)	Stryker Corp.	KWS	Class II	2019-02-15
K182932	RS85 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-02-15
K182332	PhantomMSK	Orthogrid Systems, Inc	LLZ	Class II	2019-02-15
K182293	OsseOne Dental Implant System	Synoross dba Osseone	DZE	Class II	2019-02-15
K181534	Cirrus Hd-Oct	Carl Zeiss Meditec Inc	OBO	Class II	2019-02-15
K181507	PREVENA RESTOR(TM) Incision Management System	KCI USA, Inc.	OMP	Class II	2019-02-15
K181393	Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP	Valmed SRL	KPE	Class II	2019-02-15
K181353	Lunderquist® Fixed Core Wire Guide	Cook Incorporated	DQX	Class II	2019-02-15
K181194	SmartMouth DryMouth Oral Rinse	Triumph Pharmaceuticals Inc	LFD	Unclassified	2019-02-15
K173937	SpiroSphere	eResearchTechnology GmbH	BTY	Class II	2019-02-15
K190074	Presero 3D Scanning System	Certis Health	LLZ	Class II	2019-02-14
K183635	PhotoFix Decellularized Bovine Pericardium	Artivion, Inc.	PSQ	Class II	2019-02-14
K183569	DD cube ONE ML	Dental Direkt GmbH	EIH	Class II	2019-02-14
K183506	HEALIX ADVANCE Anchor with DYNACORD Suture	Medos International SARL	MAI	Class II	2019-02-14
K183317	AdvantageRib System	Sig Medical Corp.	HRS	Class II	2019-02-14
K183221	MAGNETOM Amira, MAGNETOM Sempra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2019-02-14
K183206	Dexcom G6 Continuous Glucose Monitoring System	Dexcom, Inc.	QBJ	Class II	2019-02-14
K183196	Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker	Stryker Corp.	OLO	Class II	2019-02-14
K183083	Shoreline Cervical Interbody RT System	SeaSpine Orthopedics Corporation	ODP	Class II	2019-02-14
K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Philips Medical Systems Nederland B.V.	LNH	Class II	2019-02-14
K182756	MyoStrain 5.1	Myocardial Solutions	LNH	Class II	2019-02-14
K182705	Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups	b-ONE Ortho Corp.	LZO	Class II	2019-02-14
K182677	DynaNail Mini	Medshape, Inc.	HWC	Class II	2019-02-14
K182188	Ion Endoluminal System ; Flexision Biopsy Needle	Intuitive Surgical, Inc.	EOQ	Class II	2019-02-14
K181930	GMC Wrist Automatic Blood Pressure Monitor	Gmc, Inc.	DXN	Class II	2019-02-14
K181315	Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing	Winner Medical Co., Ltd.	FRO	Unclassified	2019-02-14
DEN180058	t:slim X2 insulin pump with interoperable technology	Tandem Diabetes Care, Inc.	QFG	Class II	2019-02-14
K183161	SnapShot Freeze 2	GE Healthcare	JAK	Class II	2019-02-13
K182991	EPIC Extremity Fusion Plate System	Epic Extremity, LLC	HRS	Class II	2019-02-13
K182974	NuVasive Reline System	Nu Vasive, Incorporated	NKB	Class II	2019-02-13
K182915	ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube	Envizion Medical, Ltd.	KNT	Class II	2019-02-13
K182874	Fenom Pro Nitric Oxide Test	Spirosure, Inc.	MXA	Class II	2019-02-13
K182661	Kava and Kava with Herbst	Sketchpad Innovations, LLC	LRK	Class II	2019-02-13
K181661	QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System	Bio-Rad Laboratories Inc.	OYX	Class II	2019-02-13
K181508	U&U Blood Collection Sets	U&u Medical Technology Co., Ltd	FMI	Class II	2019-02-13
K190075	Aurora Evacuator	Rebound Therapeutics, Corporation	GEI	Class II	2019-02-12
K190056	KOWA VK-2s	Kowa Co. Ltd. Chofu	NFJ	Class II	2019-02-12
K183637	Cruxcan (CRX-1000)	Cruxell Corp.	MUH	Class II	2019-02-12
K183375	Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode	Horiba Ltd.	JJE	Class I	2019-02-12
K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens	Bausch & Lomb Incorporated	HQD	Class II	2019-02-12
K183127	MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2019-02-12
K182934	FORA P100 Blood Pressure Monitoring System	Taidoc Technology Corporation	DXN	Class II	2019-02-12
K181955	WiEMSpro	Medical Cables S.L.	NGX	Class II	2019-02-12
K190085	Journey II Unicompartmental Knee System	Smith & Nephew, Inc.	HSX	Class II	2019-02-11
K190078	IntraSight	Volcano Corporation	DSA	Class II	2019-02-11