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 343 of 3528

510(k) clearances, page 343 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211393	Selethru(TM) NC PTCA Balloon Dilatation Catheter	Kossel MedTech (Suzhou) Co., Ltd.	LOX	Class II	2021-07-02
K210199	Ricoh Meg	Ricoh Company, Ltd.	OLX	Class II	2021-07-02
K210127	iQ200 System, iChemVELOCITY Automated Urine Chemistry System	Siemens Healthcare Diagnostics Inc.	LKM	Class II	2021-07-02
K210097	Estar-Z	OSSTEM Implant Co., Ltd.	EIH	Class II	2021-07-02
K203800	SyntrFuge System	Syntr Health Technologies, Inc.	MUU	Class II	2021-07-02
K203591	Single-use Medical Face Mask	Conod Medical Co., Ltd.	FXX	Class II	2021-07-02
K203498	LX9max	Daesung Maref Co.,Ltd	IRP	Class II	2021-07-02
K203441	The Alma Hybrid Laser System	Alma Lasers Ltd.	GEX	Class II	2021-07-02
K203347	Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask	Suzhou Yuyue Medical Technology Co., Ltd	BZD	Class II	2021-07-02
K202954	Disposable Surgical Mask	Xiamen Probtain Medical Techology Co., Ltd.	FXX	Class II	2021-07-02
K202570	Insulin Syringe, Insulin Syringe with Safety Retractable	Jiangsu Micsafe Medical Technology Co., Ltd	MEG	Class II	2021-07-02
K202241	LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)	HAMILTON THORNE, Inc.	MRX	Class II	2021-07-02
K200256	ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay	Siemens Healthcare Diagnostics Inc.	PDJ	Class II	2021-07-02
K211782	ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9	Controlrad, Inc.	OWB	Class II	2021-07-01
K211511	decimal Bolus	.Decimal, Inc.	MUJ	Class II	2021-07-01
K211411	Penumbra System (RED 68 Reperfusion Catheter)	Penumbra Inc.	NRY	Class II	2021-07-01
K211337	DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2021-07-01
K211007	EZ-TRAXTM Persona Knee Containment Device	K1 Medical, LLC	KCT	Class II	2021-07-01
K210910	Snore Bandit	Snorebandit, LLC	LRK	Class II	2021-07-01
K210611	MAGNETOM Free.Max	Siemens Medical Solutions USA, Inc.	LNH	Class II	2021-07-01
K210326	Bravo G4 Chamber Autoclave	Scican Ltd.	FLE	Class II	2021-07-01
K203672	MAZIC Claro CAD and MAZIC Claro Press	Vericom Co., Ltd.	EIH	Class II	2021-07-01
K203575	GlidePath Retro Long-Term Hemodialysis Catheter	C.R. Bard Inc	MSD	Class II	2021-07-01
K203369	Avance Solo Negative Pressure Wound Therapy (NPWT) System	Molnlycke Health Care, US LLC	OMP	Class II	2021-07-01
K203262	Cannula for Organ Perfusion	Bridge to Life Ltd	KDN	Class II	2021-07-01
K202171	Pulmogine Vibrating Mesh Nebulizer	Hcmed Innovations Co., Ltd.	CAF	Class II	2021-07-01
K211768	LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE	Waldemar Link GmbH & Co. KG	KRO	Class II	2021-06-30
K211025	Oral/Enteral Syringe with ENFit connector	Ningbo Tianyi Medical Appliance CO., Ltd.	PNR	Class II	2021-06-30
K210904	Metapaste Plus	Meta Biomed Co., Ltd.	KIF	Class II	2021-06-30
K210753	KardiaMobile 6L	AliveCor	DXH	Class II	2021-06-30
K210560	Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph	Philips North America LLC	DPS	Class II	2021-06-30
K210542	aprevo Transforaminal IBF	Carlsmed, Inc.	MAX	Class II	2021-06-30
K210512	LUMINELLE DTx System	Uvision360, Inc.	FAJ	Class II	2021-06-30
K210377	Stryker iBur hubs and cutting accessories	Stryker Corp.	HBE	Class II	2021-06-30
K210044	Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System	Spinal Elements, Inc	MAX	Class II	2021-06-30
K203717	Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0	Fujifilm Corporaton	GCJ	Class II	2021-06-30
K203057	Quantum Perfusion Arterial Cannula Graft	Spectrum Medical Inc	DWF	Class II	2021-06-30
K201206	Pivot Breath Sensor	Carrot, Inc.	CCJ	Class II	2021-06-30
K211038	Biophotas Celluma RESTORE	Biophotas, Inc.	OAP	Class II	2021-06-29
K210954	Synergy	Yrs Group, Inc.	OHS	Class II	2021-06-29
K210843	Stage	Spintech, Inc.	LNH	Class II	2021-06-29
K210837	Smith & Nephew Plates and Screws	Smith & Nephew, Inc.	HRS	Class II	2021-06-29
K210645	RayStation 10.1	RaySearch Laboratories AB (publ)	MUJ	Class II	2021-06-29
K210445	Nordiwell Surprotect Face Mask	Changzhou Combat Protective Equipment Co., Ltd.	FXX	Class II	2021-06-29
K210437	Standard Bougie, 38 Fr.	Standard Bariatrics	KNT	Class II	2021-06-29
K203733	12MP Color Digital Mammography LCD Monitor CL-S1200	JVCKENWOOD Corporation	PGY	Class II	2021-06-29
K203645	Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40	Supersonic Imagine	IYN	Class II	2021-06-29
K210869	Phantom Hindfoot TTC/TC Nail System	Paragon 28	HSB	Class II	2021-06-28
K210775	White Nitrile Powder Free Patient Examination Glove, Non Sterile	Onetexx Sdn Bhd	LZA	Class I	2021-06-28
K210587	Violet Nitrile Powder Free Patient Examination Glove, Non Sterile	Onetexx Sdn Bhd	LZA	Class I	2021-06-28