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 2026-11-05, 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 1303 of 3531

510(k) clearances, page 1303 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052190	Fetal Monitor, Models Bt-300 and Bt-200	Bistos co., Ltd.	HGM	Class II	2005-10-04
K052164	Magnetom Systems with Software Syngo Mr 2006A	Siemens Medical Solutions USA, Inc.	LNH	Class II	2005-10-04
K052143	Quanta Lite Gliadin Iga II	Inova Diagnostics, Inc.	MST	Class II	2005-10-04
K052142	Quanta Lite Gliadin Igg II	Inova Diagnostics, Inc.	MST	Class II	2005-10-04
K052010	Hba1c Linearity Set	Cone Bioproducts	JJX	Class I	2005-10-04
K051943	Sureflow Safety Infusion Device	Intrasafe Medical, LLC	FPA	Class II	2005-10-04
K051783	Artsana Pen Needles, Artsana Injection Needles	Artsana S.P.A	FMI	Class II	2005-10-04
K051577	Immunalysis Methamphetamine Elisa for Oral Fluids	Immunalysis Corporation	LAF	Class II	2005-10-04
K051514	Assure Pro Blood Glucose Monitoring System, Model 460002	Arkray Factory USA, Inc.	NBW	Class II	2005-10-04
K050124	Porous Coated Acetabular Components	Zimmer GmbH	KWA	Class III	2005-10-04
K043494	Mastel Laser Clean Room, Model Ebs-100	Mastel Precision Surgical Instruments, Inc.	FYD	Class II	2005-10-04
K052516	Steritec Container Cord - Ci 135, Steritec Process Indicator Labels - Ci 140, Steritec Process Indicator Dots - Ci 137	Steritec Products, Inc.	JOJ	Class II	2005-10-03
K052359	Ibl Cortisol Lia Test Kit	Lehnus & Associates Consulting	CGR	Class II	2005-10-03
K052269	Bd Phoenix Automated Microbiology System -Ciprofloxacin Gn	Becton Dickinson & Co	LON	Class II	2005-10-03
K052242	Advia Chemistry Microalbumin Controls	Medrad, Inc.	JJW	Class I	2005-10-03
K052193	Ise Compensator	Roche Diagnostics GmbH	JIT	Class II	2005-10-03
K051969	Tricat Ria (Adrenalin/noradrenalin/dopamine); Katcombi Ria (Adrenalin/noradrenalin); Noradrenalin Ria	Ibl GmbH	CHQ	Class I	2005-10-03
K051872	Mk-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models: Ls2011	MK-dent GmbH	EFB	Class I	2005-10-03
K051806	Care Fecal Occult Blood Test, Model Kt313	Epitope Diagnostics, Inc.	KHE	Class II	2005-10-03
K050286	Fidis Connective 8	Biomedical Diagnostics (Bmd) SA	LLL	Class II	2005-10-03
K052551	Devon Standard Syringe, Hypodermic Needle and Insulin Syringe	Devon Safety Products, Inc.	FMF	Class II	2005-09-30
K052529	E-2320 Pa S	Barco N.V.	LLZ	Class II	2005-09-30
K052464	Tina-Quant Hemoglobin A1c Gen.2 Test	Roche Diagnostics GmbH	LCP	Class II	2005-09-30
K052352	Color Coronis 2Mp-21 and Mfcd 2321	Barco N.V.	LLZ	Class II	2005-09-30
K052273	Polymer Coated Latex Examination Gloves, Powder Free, Non-Sterile	Pt Mahakarya Inti Buana	LYY	Class I	2005-09-30
K052250	Bd Phoenix Automated Microbiology System - Tobramycin (Gp) 0.5-16Ug/ml	Becton Dickinson & Co	LON	Class II	2005-09-30
K052220	Iplan Rt Fibertracking	Brainlab, Inc.	IYE	Class II	2005-09-30
K052063	Huanqiu Heating Lamp	A & a Medical Supplies Inc.	ILY	Class II	2005-09-30
K051944	Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta Slt, Selecta Duo), Delivery Device and Accessories	Lumenis Ltd	HQF	Class II	2005-09-30
K051913	Powdered Latex Patient Examination Gloves	Shinemound Enterprise, Inc.	LYY	Class I	2005-09-30
K051789	Visante Oct	Carl Zeiss Meditec Inc	HLI	Class II	2005-09-30
K051779	Androflow - Respiratory Rate Monitor	Andromed, Inc.	BZQ	Class II	2005-09-30
K050097	Techno-Scope Visual Stethoscope	Techtrade LLC	DQD	Class II	2005-09-30
K042564	Hemor-Rite Cryotheraphy	Fama Holdings International Corp	LKX	Unclassified	2005-09-30
K052517	Site-Rite 5 Ultrasound System	C.R. Bard Inc	ITX	Class II	2005-09-29
K052415	Power Linear Cutter Reusable Digital Loading Units with Reloads	Power Medical Interventions, Inc.	GDW	Class II	2005-09-29
K052311	Vitek 2 Gram Negative Tigecycline	bioMerieux, Inc.	LON	Class II	2005-09-29
K052083	Navistar Rmt Steerable Tip Diagnostic Catheter	Biosense Webster Inc	DRF	Class II	2005-09-29
K052027	Opti Lion Electrolyte Analyzer, Model Gd7200	Opti Medical Systems Inc	CGZ	Class II	2005-09-29
K051843	Copeland Eas Humeral Resurfacing Heads	Zimmer GmbH	HSD	Class II	2005-09-29
K051701	Vicryl * Mesh Bag	Ethicon, Inc	FTL	Class II	2005-09-29
K051698	Merries Uni-Osteo, Model Cs30250-Cs10102	Merries International, Inc.	MQV	Class II	2005-09-29
K051569	Ringloc Bi-Polar Acetabular Component	Zimmer GmbH	JDI	Class II	2005-09-29
K051332	Advanta T-Graft	Atrium Medical Corporation	DSY	Class II	2005-09-29
K043099	Lineage Ha Acetabular Shells	Wrightmedicaltechnologyinc	KWA	Class III	2005-09-29
K042998	Refstar Rmt External Reference Patch	Biosense Webster Inc	DRF	Class II	2005-09-29
K042681	Carto Rmt Ep Navigation System	Biosense Webster Inc	DQK	Class II	2005-09-29
K052614	Low Profile Plate and Screw System	Arthrex GmbH	HRS	Class II	2005-09-28
K052593	Fusion Curing Light	Dentlight Inc.	EBZ	Class II	2005-09-28
K052478	Mfcd 1219, Mfcd 1219 Ts	Barco N.V.	LLZ	Class II	2005-09-28