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 365 of 3528

510(k) clearances, page 365 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K203702	Vinyl Examination Gloves (Yellow)	Xinying Trading Co., Ltd.	LYZ	Class I	2021-02-12
K203546	gammaCore Sapphire	Electrocore, Inc.	PKR	Class II	2021-02-12
K203355	Straumann TLX Novaloc and Cementable Abutments	Straumann USA, LLC	NHA	Class II	2021-02-12
K203191	LYDUS Nitrile Examination Gloves, Powder Free	Nathan Trading Co., Ltd.	LZA	Class I	2021-02-12
K203091	MucoLock Oral Gel	PCCA, Inc.	OLR	Unclassified	2021-02-12
K202651	NOA Sleep Apnea and Snoring Device	Orthoapnea S.L.	LRK	Class II	2021-02-12
K202611	Catalyst OrthoScience R1 Reverse Shoulder System	CATALYST ORTHOSCIENCE Inc	PHX	Class II	2021-02-12
K202368	Infrared Thermometer	Shandong Bittel Intelligent Technology Co., Ltd.	FLL	Class II	2021-02-12
K202341	Disposable Surgical Mask	Shanghai Jianzhong Medical Packaging Co., Ltd.	FXX	Class II	2021-02-12
K202281	EDS Bioceramic Sealer (Bioseal)	Essential Dental Systems, Inc.	KIF	Class II	2021-02-12
K201799	CleaniCal	Maruchi	EJK	Class II	2021-02-12
K201628	Panda iRes Warmer, Giraffe Warmer	GE Healthcare	FMT	Class II	2021-02-12
K201545	Surgical Face Mask	Amphastar Nanjing Pharmaceuticals, Inc.	FXX	Class II	2021-02-12
K201490	Electro Flo 6 Airway Clearance System	Med Systems	BYI	Class II	2021-02-12
K201356	Plastic LOR Syringe	Jiangsu Caina Medical Co., Ltd	CAZ	Class II	2021-02-12
K200551	MectaLIF Transforaminal TiPEEK	Medacta Inernational SA	MAX	Class II	2021-02-12
K193280	MedCAD® AccuPlate® Patient-Specific Plate	MedCAD	JEY	Class II	2021-02-12
K192742	Straumann Variobase C	Straumann USA, LLC	NHA	Class II	2021-02-12
K210089	CATSmart, Automated Blood Processing Autotransfusion System	Fresenius Kabi AB	CAC	Class II	2021-02-11
K203385	TenoTac Soft Tissue Fixation System	Paragon 28	MBI	Class II	2021-02-11
K202219	VORTRAN GO2VENT with PEEP Valve	Vortran Medical Technology 1, Inc	BTL	Class II	2021-02-11
K201292	Traus Sip20	Saeshin Precision Co., Ltd.	EBW	Class I	2021-02-11
K201222	Bio-C Repair Ion+	Angelus Industria de Produtos Odontologicos S/A	KIF	Class II	2021-02-11
K193662	Ezlymph, Ezlymph M	Eezcare Medical Corp.	JOW	Class II	2021-02-11
K192839	DSP Implant System	D.S.P Industrial Eireli	DZE	Class II	2021-02-11
K203632	da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments	Intuitive Surgical, Inc.	NAY	Class II	2021-02-10
K203557	EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing	Encore Medical, LP	LPH	Class II	2021-02-10
K203513	SLENDERTONE Evolve Abs, Type 735	Bio-Medical Research, Ltd.	NGX	Class II	2021-02-10
K203490	FORE-SIGHT ELITE Absolute Tissue Oximeter	Edwards Lifesciences LLC	MUD	Class II	2021-02-10
K202605	Standard Procedure Mask, Standard Surgical Mask	Jiangsu Medplus Non-woven Manufacturer Co.,Ltd.	FXX	Class II	2021-02-10
K202174	Digital NeuroPort Biopotential Signal Processing System	Blackrock Microsystems	GWL	Class II	2021-02-10
K201536	Infrared Forehead Thermometer	Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.	FLL	Class II	2021-02-10
K201454	DSG Connect Technology	Spineguard, Inc.	PDQ	Class II	2021-02-10
K201332	Meditech ABPM-06 (BP6)	Meditech	DXN	Class II	2021-02-10
K200675	Hi bebe super (Models BT-150S and BT-150L)	Bistos co., Ltd.	HGX	Class II	2021-02-10
K191897	Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)	Dongguan Prestige Sporting Goods Co., Ltd.	INI	Class II	2021-02-10
K210272	LIAISON Anti-HAV	Diasorin Inc.	LOL	Class II	2021-02-09
K210083	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7	Penumbra Inc.	QEW	Class II	2021-02-09
K203265	nPro Surgical Mask	NP Medical	FXX	Class II	2021-02-09
K203103	Synapse 3D, Synapse 3D Base Tools v6.1	FUJIFILM Corporation	LLZ	Class II	2021-02-09
K203079	MR Conditional Sticky Pad Electrode	Rhythmlink International, LLC	GXY	Class II	2021-02-09
K203055	Stryker PEEK Customized Cranial Implant Kit	Stryker Corp.	GWO	Class II	2021-02-09
K202850	Concerto Versa, Detachable Coil	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	KRD	Class II	2021-02-09
K201583	SmartCT R1.0	Philips Medical Systems Nederland B.V.	OWB	Class II	2021-02-09
K203069	HydroMID	Access Vascular, Inc	FOZ	Class II	2021-02-08
K202942	Straumann 4 mm Short Implants	Straumann USA, LLC	DZE	Class II	2021-02-08
K201635	MouthLab Vital Signs Monitoring System	Multisensor Diagnostics (dba Aidar Health)	MWI	Class II	2021-02-06
K200276	SPEAC System	Brain Sentinel, Inc.	POS	Class II	2021-02-06
K210063	Freudenberg Surgical Mask	Freudenberg Performance Materials LP	FXX	Class II	2021-02-05
K210055	Cios Alpha	Siemens Medical Solutions USA, Inc.	OWB	Class II	2021-02-05