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 1412 of 3531

510(k) clearances, page 1412 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032067	Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray	Proxima Therapeutics, Inc.	JAQ	Class II	2004-02-10
K034030	Apogee Elite	Cynosure, LLC	GEX	Class II	2004-02-09
K033713	Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# Df92a	Siemens Healthcare Diagnostics Inc.	DIO	Class II	2004-02-09
K033674	Multigent Hemoglobin A1c (Reagents), Hb A1c Calibrators and Hb A1c Controls	Seradyn, Inc.	LCP	Class II	2004-02-09
K033575	One.click Needle	B.Braun Medical, Inc.	FMI	Class II	2004-02-09
K032125	Cstat, Models 09-0014-01 and 09-0014-02	Vascular Control Systems, Inc.	DXC	Class II	2004-02-09
K031741	Medley Etco2 Module (Includes Accessories), Model 8300	CareFusion 303, Inc	CCK	Class II	2004-02-09
K040142	Ensphere Tempo Jetstream Workspace Cardiology Module	Philips North America LLC	LLZ	Class II	2004-02-06
K034060	Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)	Hong Huang Tang Industrial Co., Ltd.	LYZ	Class I	2004-02-06
K033999	Sedline with Frontal Psi	Physiometrix, Inc.	OLW	Class II	2004-02-06
K033974	Hermes Bond	3M Espe AG Dental Products	KLE	Class II	2004-02-06
K033823	Respironics Custom II Oral Appliance	Respironics, Inc.	LRK	Class II	2004-02-06
K033822	Respironics Custom I Oral Appliance	Respironics, Inc.	LRK	Class II	2004-02-06
K033756	Volar Radius Plate with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	HRS	Class II	2004-02-06
K033703	Ideal 1 Orthodontic Bracket Adhesive	Dentsply Intl.	DYH	Class II	2004-02-06
K033213	Codent Dental Air-Powered Handpiece, Model Hps	Codent Technical Industry Co.,Ltd.	EFB	Class I	2004-02-06
K032562	Proceara Copings and Pontic	Nobel Biocare AB	ELL	Class II	2004-02-06
K031434	Bawmed E-Z Bag Resuscitator	Bawmed UK	BTM	Class II	2004-02-06
K030685	Teeth in an Hour - Ark Implant Concept	Nobel Biocare AB	DZE	Class II	2004-02-06
K040101	Modification to Diadexus Plac Test	Diadexus, Inc.	NOE	Class II	2004-02-05
K033844	Synthes Anterior Cervical Compression System	Synthes (USA) Products LLC	KWQ	Class II	2004-02-05
K033777	Ultrasense Af Blue Powder-Free Nitrile Examination Gloves	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2004-02-05
K033751	Aegis Pit & Fissure Sealant with Acp	Harry J. Bosworth Co.	EBC	Class II	2004-02-05
K033618	Synthes (USA) Retrograde/antegrade Femoral Nail System	Synthes (USA) Products LLC	HSB	Class II	2004-02-05
K033563	Smartset Ghv Gentamicin Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2004-02-05
K033527	Intradyn Pediatric Hemostasis Introducer	B.Braun Medical, Inc.	DYB	Class II	2004-02-05
K033451	Heartrak Smart At/heartrak Smart2	Universal Medical, Inc.	DXH	Class II	2004-02-05
K033382	Smartset Gmv Endurance Gentamicin Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2004-02-05
K033272	Depuy Sigma Tibial Inserts	Depuy Orthopaedics Inc.	JWH	Class II	2004-02-05
K033089	Hemostatix, Model 2400Z Thermal Scalpel System	Gyrus Ent LLC	GEI	Class II	2004-02-05
K032631	Innerbloc Lr Surgical Gowns Based on Gore Lr Fabric (Reusable 100X)	Lac-Mac Limited	FYA	Class II	2004-02-05
K032416	Vintage Press, Vintage Lf, Vintage Lf Stain	Shofu Dental Corp.	EIH	Class II	2004-02-05
K031492	Mossmed Dual Intermittent Aspirator	Moss Medical Products	KNT	Class II	2004-02-05
K031363	Qca (Version 3.1)	Cell Analysis, Inc.	NQN	Class II	2004-02-05
K030877	Trimed Radial Bullet	Tri-Med, Inc.	HRS	Class II	2004-02-05
K030837	40 L High Flow Insufflator F108	Novanta Medical GmbH	HIF	Class II	2004-02-05
K040098	Varnishamerica	Medical Products Laboratories, Inc.	LBH	Class II	2004-02-04
K040038	Curved Cutter Stapler, Models Cs40b, Cs40g; Reload for Curved Stapler, Models Cr40b, Cr40g	Ethicon Endo-Surgery Inc	GDW	Class II	2004-02-04
K040024	Surgassist Circular Stapler Digital Loading Units - 29 Mm, Model Cs29	Power Medical Interventions, Inc.	GDW	Class II	2004-02-04
K033997	Solera Plus Thrombectomy Catheter, 55 Cm and 110 Cm, Models Bac Smg 007 055, Bac Smg 007 110	Bacchus Vascular, Inc.	MCW	Class II	2004-02-04
K033969	Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2004-02-04
K033952	Perifix Catheter Connector	B.Braun Medical, Inc.	CAZ	Class II	2004-02-04
K033942	Thermage Thermacool System	Solta Medical, Inc.	GEI	Class II	2004-02-04
K033813	Micrus Modified Microcoil System, Cerecyte	Micrus Corp.	HCG	Class II	2004-02-04
K033761	Gelspheres / Beadblock Compressible Microspheres	BIOCOMPATIBLES U.K. Limited, a BTG Company	HCG	Class II	2004-02-04
K033719	Bard Tigertail Ureteral Catheter	C.R. Bard Inc	KOD	Class II	2004-02-04
K033706	Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	LPS	Class II	2004-02-04
K033652	Minimally Invasive Solutions Osteotomy Guide Instrument	Zimmer GmbH	GEI	Class II	2004-02-04
K033497	Bard Luminexx 3 Biliary Stent and Delivery System	C.R. Bard Inc	FGE	Class II	2004-02-04
K033471	Phospholin Es and Calcium Chloride	R2 Diagnostics, Inc.	GGW	Class II	2004-02-04