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 1482 of 3531

510(k) clearances, page 1482 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023988	Ge Discovery Ls System	GE Healthcare	KPS	Class II	2003-02-04
K023830	Airocide Ti02	Kes Science & Technology, Inc.	FRA	Class II	2003-02-04
K023828	K-Assay C-Reactive Protein (3), K-Assay Crp Multi-Calibrator D, K-Assay Crp Multi-Calibrator E, K-Assay Crp Multi-Calibr	Kamiya Biomedical Company, LLC	DCK	Class II	2003-02-04
K023715	Starmatrix Powder Free Latex Examination Gloves, with Protein Labeling Claim	Starmatrix Sdn Bhd	LYY	Class I	2003-02-04
K023540	Snap Kover, Model 01-2020; Snap Kaps, Model 03-Kp09	Valumed	MMP	Class II	2003-02-04
K023510	Trutek Select Model Tt-1001	Trutek Corp	FLL	Class II	2003-02-04
K022863	Hts Coil	Jockey Club Mri Engineering Center	MOS	Class II	2003-02-04
K022364	Navitrack System Total Hip Replacement,model 900.200	Orthosoft, Inc.	HAW	Class II	2003-02-04
K014001	Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3	Oral Osteodistraction, L.P.	MQN	Class II	2003-02-04
K030142	Thermacool Tc System	Solta Medical, Inc.	GEI	Class II	2003-02-03
K030108	Arthrocare ENT Coblator Surgery System	ArthroCare Corporation	GEI	Class II	2003-02-03
K024355	Evergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	2003-02-03
K024118	Ultraflow Hpc Flow Directed Micro Catheter, Models 105-5065 and 105-5066	Medtronic, Inc.	KRA	Class II	2003-02-03
K024016	Powdered Vinyl Examination Gloves	Top Glove (Zhangjiagang) Co., Ltd.	LYZ	Class I	2003-02-03
K023729	Siascope II	Astron Clinica Limited	PSN	Class II	2003-02-03
K023725	Hemorrhage Occluder Pin (Hop), Model 337-247	Marina Medical Instruments Inc.	GDW	Class II	2003-02-03
K023724	Duracon Cs Lipped Extra Small Tibial Insert	Howmedica Osteonics Corp	JWH	Class II	2003-02-03
K023714	Reprocessed External Fixation Device	Alliance Medical Corp.	KTT	Class II	2003-02-03
K022803	Waterlase for Apicoectomy	Biolase MG LLC	MXF	Class II	2003-02-03
K022483	Actisorb Silver 220 Antimicrobial Binding Dressing	Johnson & Johnson MEDICAL GmbH	FRO	Unclassified	2003-02-03
K022416	Contreet Foam Adhesive/non-Adhesive	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2003-02-03
K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	MMX	Class II	2003-02-03
K020318	Scivolutions Various Antibacterial Bandages	Scivolutions, Inc.	FRO	Unclassified	2003-02-03
K030169	Setpoint Chemistry Calibrator	Medrad, Inc.	JIX	Class II	2003-01-31
K030144	Modification to Pentra 60 and Pentra 60C+	Horiba Instruments Incorporated	GKZ	Class II	2003-01-31
K024152	Bd Phoenix Automated Microbiology System - Rifampin 0.25-32 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-01-31
K024053	Permanent Pacing Leads, Models Physique Pb and Pjb	Oscor Inc.	DTB	Class III	2003-01-31
K023984	Modification to Olympus Bronchoscopes Bf-40 Series, Bf-240 Series, and Bf-160 Series	Olympus Optical Co., Ltd.	EOQ	Class II	2003-01-31
K023981	Ahl Generic Glass Ionomer Luting Cement	Advanced Healthcare Ltd.	EMA	Class II	2003-01-31
K023792	Calibration Pack, Models A9100-101S and A9100-103S	Thermo Orion	JIX	Class II	2003-01-31
K023712	Advantage Multiple Drugs of Abuse Test	Advantage Diagnostics Corp.	DKZ	Class II	2003-01-31
K023561	Itc Hgb Pro Professional Hemoglobin Testing System	Accriva Diagnostics, Inc.	GKR	Class II	2003-01-31
K022961	Rtdoseplan	Math Resolutions, LLC	MUJ	Class II	2003-01-31
K022596	Bio-Cybernetic Cardio-Diagnosis System (Bkd)	Clover Hi-Tech, Inc.	DQK	Class II	2003-01-31
K022326	Radiomed Marker	Radiomed Corporation	JAK	Class II	2003-01-31
DEN020001	Breastview Visual Mapping System	Assurance Medical	NKA	Class II	2003-01-31
K024017	Bayer Advia Centaur Her-2/Neu Assay	Bayer Corp.	NCW	Class II	2003-01-30
K023976	Acroseal Root Canal or Apical Sealer	Septodont S.A.S.	KIF	Class II	2003-01-30
K023814	Gradia Direct	GC America Inc.	EBF	Class II	2003-01-30
K023704	Ksea Scb Acc Control	Karl Storz Endoscopy-America, Inc.	FTA	Class II	2003-01-30
K023703	Bi-Ostetic	Berkeley Advanced Biomaterials	MQV	Class II	2003-01-30
K023701	Angionew-IV	Living Data Technologies Corporation	DRN	Class II	2003-01-30
K023688	Lemaitre Vascular Disposable Vein Stripper	LeMaitre Vascular Inc.	GAF	Class I	2003-01-30
K022221	Truflow Long-Term and Short-Term Dual-Lumen Dialysis Catheters	Abbott Medical	MPB	Class II	2003-01-30
K021340	Aecp-a, Automatic External Counterpulsation Device	External Counterpulsation Lab	DRN	Class II	2003-01-30
K030206	Apex 90	We Dong Myung Dental Industrial Co., Ltd.	EJT	Class II	2003-01-29
K030191	Terason Model 2000/Bas Portable Ultrasound System	Teratech Corp.	IYN	Class II	2003-01-29
K030049	Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086	Rubicor Medical, Inc.	GEI	Class II	2003-01-29
K023835	Devex Mesh System	Depuyacromed	MQP	Class II	2003-01-29
K023705	Bicon Transitional Implant (Bti) System	Bicon, LLC	DZE	Class II	2003-01-29