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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 932 of 3530

510(k) clearances, page 932 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112601	Intricon Datrix Sirona Event/ Holter Recorder	Intricon Datrix Corporation	MWJ	Class II	2011-11-09
K112416	Cpk Reagent	Vital Diagnostics (Manufacturing) Ptyltd	CGS	Class II	2011-11-09
K112303	Rubicon Support Catheter	Boston Scientific Corporation	DQY	Class II	2011-11-09
K112190	Patient Monitor	Mediana Co., Ltd.	MHX	Class II	2011-11-09
K112152	Cercon Ht	Dentsply International, Inc.	EIH	Class II	2011-11-09
K111901	Asa 'Mphi Family Diode Laser	Cynosure, LLC	ILY	Class II	2011-11-09
K111645	Fd TENS 2050 or Slide TENS Model Fd2050	FUJI Dynamics Limited	GZJ	Class II	2011-11-09
K111509	Sweetspot Diabetes Data Management Service	Sweetspot Diabetes Care, Inc.	NBW	Class II	2011-11-09
K111356	Asimanager - at	Arlington Scientific, Inc.	JQT	Class I	2011-11-09
K111210	T:slim (Tm) Insulin Delivery System	Tandem Diabetes Care, Inc.	LZG	Class II	2011-11-09
K111097	Humelock Cemented Shoulder Prosthesis	Fx Shoulder Solutions SAS	HSD	Class II	2011-11-09
K110562	Telamon Peek Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2011-11-09
K110442	Nanovis Intervertebral Body Fusion System	Nanovis, LLC	ODP	Class II	2011-11-09
K110276	Powerpress Unit	Hanuri Distribution, Inc	JOW	Class II	2011-11-09
K103575	Spiro Pd	Pmd Healthcare	BZG	Class II	2011-11-09
K102752	Stingray Ultralite Disposable Irrigating Bipolar Forceps	Stingray Surgical Products	GEI	Class II	2011-11-09
K113129	Spectralis Anterior Segment Module (Spectralis Asm)	Heidelberg Engineering GmbH	OBO	Class II	2011-11-08
K112957	Hi-Torque Powerturn	Abbott Vascular-Cardiac Therapies	DQX	Class II	2011-11-08
K112447	Grandio Core Dual Cure	Voco GmbH	EBF	Class II	2011-11-08
K112359	Prow Fusion	Nlt Spine, Ltd.	MAX	Class II	2011-11-08
K112186	Fiber Disk and Block	Bioloren SRL	EBG	Class II	2011-11-08
K112036	Calix Pc Spinal Implant System	Xtant Medical Holdings, Inc.	ODP	Class II	2011-11-08
K112033	Enseal G2 Tissus Sealers	Ethicon Endo-Sugery, LLC	GEI	Class II	2011-11-08
K111930	Ackermann Europclip	Ackermann Instrumente GmbH	FZP	Class II	2011-11-08
K111692	Tumark Flex for Mammotome,tumark Flex for Atec	SOMATEX Medical Technologies GmbH	NEU	Class II	2011-11-08
K111615	Sensititre 18-24 Hr Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2011-11-08
K111273	Fir Heat Theraphy Sysyems	Shenzhen Anpan Technology Co., Ltd.	IRT	Class II	2011-11-08
K111267	Concise, Silicone Hydrogel Daily Wear Soft Contact Lens (Efrofilcon a)	Abbconcise Optical Group, LLC	LPL	Class II	2011-11-08
K110612	Fm20	Mediana Co., Ltd.	HGM	Class II	2011-11-08
K103788	Pentra C200, Ise Module and Abx Pentra Glucose Hk Cp Reagent	Horiba Abx SAS	CFR	Class II	2011-11-08
K102741	Enteral Feeding Bag and Sets	ShanDong WeiGao Group Medical Polymer Co., Ltd	KNT	Class II	2011-11-08
K112602	S6 Diagnostic Ultrasound System	Sonoscape Company Limited	IYN	Class II	2011-11-07
K112145	Monochrome Digital Mammography Lcd Monitor Ms33i2	Totoku Electric Co., Ltd.	LLZ	Class II	2011-11-07
K112068	Synthes Zero-P Variable Angle (Va)	Synthes Spine Co.Lp	OVE	Class II	2011-11-07
K111882	Laminar Flow Phaco Tips	Advanced Medical Optics, Inc.	HQC	Class II	2011-11-07
K103472	Nuface Plus	Carol Cole Company	NFO	Class II	2011-11-07
K101863	It/if Control	Sebia, Inc.	JJY	Class I	2011-11-07
K112603	Access Hybritech P2psa Qc on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2011-11-04
K112509	Trimed Clavicle Fixation System	Trimed Inc	HRS	Class II	2011-11-04
K112408	Poly-Chem 90 Ise Module	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	CEM	Class II	2011-11-04
K112397	Ortho-Jet Crystal	Lang Dental Mfg Co, Inc.	EBI	Class II	2011-11-04
K112285	Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / Rlp, Uncoated; Tibial Insert / Baseplate...	Tgm Medical, Inc.	JWH	Class II	2011-11-04
K112282	M Visum Alert Alarm Management System	Mvisum, Inc.	MSX	Class II	2011-11-04
K112278	Ascension Nugrip Cmc Implant	Ascension Orthopedic	KYI	Class II	2011-11-04
K112142	Dimension Vista Lithium Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	NDW	Class II	2011-11-04
K111923	Skin Guard, Powder Free Latex Examination Gloves, Non-Sterile	PT. Intan Hevea Industry	LYY	Class I	2011-11-04
K111885	Simplygo Portable Oxygen Concentrator	Respironics, Inc.	CAW	Class II	2011-11-04
K111858	Liftkar Pt	Sano Transportgeraete GmbH	ILK	Class II	2011-11-04
K111392	Woojeon Acupuncture Needle (=Sera Acupuncture Needle)	Woojeon Co.	MQX	Class II	2011-11-04
K111161	Perfscape V2.0	Olea Medical	LLZ	Class II	2011-11-04