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 1541 of 3531

510(k) clearances, page 1541 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K014274	Non-Mydriatic Fundus Camera, Model Nm-1000	Nidek, Inc.	HKI	Class II	2002-04-17
K013882	Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110I	OraSure Technologies, Inc.	JXM	Class II	2002-04-17
K013597	Tamponade Uterine Balloon Catheter Set	Cook Ob/Gyn	KNA	Class II	2002-04-17
K011880	Compex Sport	Compex S.A.	NGX	Class II	2002-04-17
K011793	Ksea Fiberscope	Karl Storz Endoscopy-America, Inc.	LYK	Class II	2002-04-17
K021076	Primagard Yellow Surgical Mask, Pleated, Tie-on, Pm4-307; Primagard Yellow Surgical Mask, Pleated, Ear-Loop,pm4-308; Prm	Primeline Medical Products, Inc.	FXX	Class II	2002-04-16
K021046	Cobra Cooled Surgical Probe, Model 1596X	Boston Scientific Corporation	GEI	Class II	2002-04-16
K020963	Taperloc Porous Femoral Stem & Ha Taperloc Porous Lateralized Femoral Stem	Biomet Orthopedics, Inc.	MEH	Class II	2002-04-16
K020951	H/s Catheter Set (5F), Model 61-5005; H/s Catheter Set (7F), Model 61-5007	Ackrad Laboratories	LKF	Class II	2002-04-16
K020740	Roche Online Theophylline	Roche Diagnostics GmbH	KLS	Class II	2002-04-16
K020528	Intrastent Ld (Large Diameter) Stent	Sulzer Intratherapeutics, Inc.	FGE	Class II	2002-04-16
K020468	Chin Electrode	Dymedix, Inc.	GXY	Class II	2002-04-16
K020152	Synthes Vertebral Spacer Ti	Synthes (USA) Products LLC	MQP	Class II	2002-04-16
K013637	Actichrome Heparin (Anti-Fiia)	Sekisui Diagnostics, LLC	KFF	Class II	2002-04-16
K013621	Bd Saf-T Prn Luer Activated Valve, Model 385100	Becton Dickinson Infusion Therapy Systems Inc.	FPA	Class II	2002-04-16
K013300	Maxiflex Fiber Optic Energy Delivery System	Technology Delivery Systems, Inc.	GEX	Class II	2002-04-16
K020905	Nbx - Non-Bridging External Fixator	Biomet Orthopedics, Inc.	LXT	Class II	2002-04-15
K020878	Lyphochek Hemostasis, Models 798, 799	Bio-Rad	GGC	Class II	2002-04-15
K020517	Synthes Dual-Opening Uss	Synthes (USA) Products LLC	MNI	Class II	2002-04-15
K020488	Careside Trglyceride	Careside, Inc.	CDT	Class I	2002-04-15
K020435	Wound Protector/retractor	Applied Medical Resources Corp	KKX	Class II	2002-04-15
K020325	L.a.m. Ipm Wound Gel	L.A.M. Pharmaceutical, Corp.	MGQ	Unclassified	2002-04-15
K020153	Consensus Acetablar Shell, Ti Coated	Hayes Medical, Inc.	LPH	Class II	2002-04-15
K020146	Serralnyl	Serral, S.A. de C.V.	GAR	Class II	2002-04-15
K020145	Orthopaedic Innovations Renewal Acetabular Cup System	Orthopaedic Innovations, Inc.	LPH	Class II	2002-04-15
K020134	Spiral Radius 90-D Rodding System	United States Surgical, A Division of Tyco Healthc	KWP	Class II	2002-04-15
K003916	Dermalife Hydrofusion Skin & Body Care System	Scandia Manufacturing, Ltd.	IMB	Class II	2002-04-15
K021029	Abp-2000 G-3	Biotrac, Inc.	DXN	Class II	2002-04-12
K020995	Efilm Workstation with Modules	Efilm Medical, Inc.	LLZ	Class II	2002-04-12
K020824	Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238	Boston Scientific Corporation	FHN	Class II	2002-04-12
K020817	Liquichek Urine Chemistry Control	Bio-Rad Laboratories Inc.	JJY	Class I	2002-04-12
K020809	Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent	Cordis US Corp.	FGE	Class II	2002-04-12
K020697	Depilase Twin Yag Laser System	Depilase Group, Ltd.	GEX	Class II	2002-04-12
K020662	Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calibrators	Ortho-Clinical Diagnostics, Inc.	MMI	Class II	2002-04-12
K020575	Atac Direct Ldl Reagent and Atac Direct Ldl Calibrator Kits	Elan Diagnostics	MRR	Class I	2002-04-12
K020496	Hpc (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex Se-9500 and Xe-2100, Automated Hematology	Sysmex Corporation of America	GKZ	Class II	2002-04-12
K020448	Static Cranioplasty Orthosis	Eastern Cranial Affiliates	MVA	Class II	2002-04-12
K020447	Mityvac Merlin, Model 10027	Prism Enterprises, Inc.	HDB	Class II	2002-04-12
K020394	Apc Plus Adhesive	3M UNITEK Corporation	DYH	Class II	2002-04-12
K020330	Deployable Oxygen Concentration System (Docs)	Pacific Consolidated Industries LLC	CAW	Class II	2002-04-12
K020287	Dentition Integrating Material	Pulpdent Corporation	EBC	Class II	2002-04-12
K020276	8 Gauge Micromark II Tissue Marker, Models C1540 & C1535	Ethicon Endo-Surgery Inc	NEU	Class II	2002-04-12
K020219	Rpi Skin or Air Temperature Probe	Replacement Parts Industries, Inc.	FMT	Class II	2002-04-12
K020186	Conmed System 5000 Esu	Conmedcorp	GEI	Class II	2002-04-12
K020135	Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120	Conmedcorp	GEI	Class II	2002-04-12
K012657	Hygia Health Services Reprocessed Nutech Calf Wrap	Hygia Health Services, Inc.	JOW	Class II	2002-04-12
K012654	Hygia Health Services Reprocessed Huntleigh Flowtron Dvt Sleeve Models Dvt10, Dvt 20, Dvt 30, Dvt 40	Hygia Health Services, Inc.	JOW	Class II	2002-04-12
K012651	Hygia Health Services Reprocessed Huntleigh Foot Wrap Models Fg 100, Fg 200	Hygia Health Services, Inc.	JOW	Class II	2002-04-12
K012650	Hygia Health Services Reprocessed Nutech Foot Wrap	Hygia Health Services, Inc.	JOW	Class II	2002-04-12
K011903	Lifeshirt System with Vivologic Analysis Software	Vivometrics, Inc.	DQK	Class II	2002-04-12