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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 942 of 3531

510(k) clearances, page 942 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111797	27 G X 1/2 K-Pack Surshield Needle	Terumo Europe N.V.	FMI	Class II	2011-09-22
K111733	Coreleader Scar-Dimmer	Coreleader Biotech Co., Ltd	MDA	Class I	2011-09-22
K111069	Osteosymbionics, St Temporalis Implant	Osteosymbionics, LLC	MNF	Class II	2011-09-22
K110583	Sensititre Optiread	Trek Diagnostic Systems, Ltd.	LRG	Class II	2011-09-22
K112187	Fm-1000 Plus Fetal Monitor	Advanced Instrumentations, Inc.	HGM	Class II	2011-09-21
K112159	Cms-1000Fm Central Monitoring System	Advanced Instrumentations, Inc.	HGM	Class II	2011-09-21
K111973	Vaginal CT / Mr Multi Channel Applicator Set	Nucletron BV	JAQ	Class II	2011-09-21
K111936	Ortho Devlopment Ceramic Femoral Head	Ortho Development Corp.	LZO	Class II	2011-09-21
K111876	Z Bond, Prelude One	Danville Materials, Inc.	KLE	Class II	2011-09-21
K111868	Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient Coating	Medtronic, Inc.	KGO	Class I	2011-09-21
K111857	Synthetic Vinyl Examination Glove Powder Free	Inmed Gloves Factory	LYZ	Class I	2011-09-21
K111833	Virtue	Diagnosoft, Inc.	LLZ	Class II	2011-09-21
K111370	Odalys Pedicle Screw System	Kalitec Direct, LLC	MNH	Class II	2011-09-21
K110914	Triple Lumen Pfm Picc	PFM Medical GmbH	LJS	Class II	2011-09-21
K110435	Easygluco Plus Blood Glucose Monitoring System	U. S. Diagnostics, Inc.	NBW	Class II	2011-09-21
K110061	Cvm, Unconjugated Estriol (Ue3) Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2011-09-21
K101299	Accu-Chek Aviva Plus Blood Glucose Monitoring System	Roche Diagnostics GmbH	LFR	Class II	2011-09-21
K112257	Biogel Pi Orthopro Brown Surgical Glove	Molnlycke Health Care, US LLC	KGO	Class I	2011-09-20
K112253	Ceralas 147Nm Diode Laser System	Biolitec, Inc.	GEX	Class II	2011-09-20
K112225	Sorin Centrifugal Pump 5 (Cp5)	LivaNova Deutschland GmbH	DWA	Class II	2011-09-20
K111710	Full Auto Tonometer Model Tx-20	Canon Inc. -Medical Equipment Group	HKX	Class II	2011-09-20
K111576	Nt 2000 Lesioning Generator	Neuro Therm, Inc.	GXD	Class II	2011-09-20
K111451	Microplex Coil System-Vector Model 030606Xxx-V, 030610Xxx-V, 30615Xxx-V, 061020Xxx-V, 061030Xxx-V, 101530Xxx-V, 101540Xx	Terumo Cardiovascular Systems Corporation	HCG	Class II	2011-09-20
K111279	Nexwave Combo Muscle Stimulator System	Altivera Medical, Inc.	IPF	Class II	2011-09-20
K111223	Amsco Chimeron Small Steam Sterilizer	STERIS Corporation	FLE	Class II	2011-09-20
K110493	Tandemheart Pump	Cardiacassist, Inc.	KFM	Class II	2011-09-20
K101356	Spacer-G and Spacer-K	Tecres SpA	KWL	Class II	2011-09-20
K101185	Nucleic Acid Detection Immunoassay (Nadia) Psa Assay	Iris Molecular Diagnostics	OWM	Class II	2011-09-20
K112502	Procedural Strecher with Intellidrive P8000	Hill-Rom Inc.	INK	Class II	2011-09-19
K112356	Glucose Meter-Check Control Solution for Agamatrix Wavesense	Bionostics, Inc.	JJX	Class I	2011-09-19
K112236	Wondfo Methylenedioxymethamphetamine Urine Test, Wondfo Morphine Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	LAF	Class II	2011-09-19
K111912	Mobilett Mira	Siemens Medical Solutions USA, Inc.	IZL	Class II	2011-09-19
K111174	Nxstage Pureflow Sl	NxStage Medical Inc	FKR	Class II	2011-09-19
K103290	Edlen Imaging - Gemini Dusb	Edlen Imaging, LLC	MUH	Class II	2011-09-19
K112596	Acuson S2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound di	IYN	Class II	2011-09-16
K112451	S8 Diagnostic Ultrasound System	Sonoscape Company Limited	IYN	Class II	2011-09-16
K112067	Navigator Delivery System (Navigator Ds)	Carticept Medical, Inc.	FRN	Class II	2011-09-16
K111836	Permashade Veneer Cement	Ultradent Products Inc.	EMA	Class II	2011-09-16
K111782	Beautisealant	Shofu Dental Corp.	EBC	Class II	2011-09-16
K111728	Emv3 Self Monitoring Blood Glucose System, Emv3 Pro Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	CGA	Class II	2011-09-16
K111720	Aviafit	Flowmedic, Ltd.	JOW	Class II	2011-09-16
K111711	Journey II Bcs Knee System	Smith & Nephew, Inc.	JWH	Class II	2011-09-16
K111629	Turon Rsp Socket Shell-Neutral Model 508-02-000, Turon Rsp Socket Shell-Offset Model 508-02-001	Encore Medical, LP	PHX	Class II	2011-09-16
K111559	Surgical Masks	Shanghai Neo-Medical Import & Export Co., Ltd.	FXX	Class II	2011-09-16
K111490	Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled Lengths and Distal Shaft Lengths	Ev3, Inc.	KRA	Class II	2011-09-16
K111355	Echobright	Life-Tech, Inc.	CAZ	Class II	2011-09-16
K111278	Z10 Wheelchair Push and Brake Assist Device	Otto Bock Healthcare LP	ITI	Class II	2011-09-16
K102778	Cellavision Dm1200 with the Body Fluid Appliction	Cellavision AB	JOY	Class II	2011-09-16
K102359	Picasso/ Picasso Lite/ Picasso Perio	Cao Group, Inc.	GEX	Class II	2011-09-16
K100806	Diacheck Blood Glucose Monitoring System Model: Premium	Delbio Incorporation	NBW	Class II	2011-09-16