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 1485 of 3531

510(k) clearances, page 1485 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030074	Linical Immunology Calibration Verifiers Levels a-E for Beckman Coulter Synchron Cx Systems	Cliniqa Corporation	JIX	Class II	2003-01-21
K023795	Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)	Lin-Zhi International Inc	JXN	Class II	2003-01-21
K023790	Ucc Dental Material	Precious Chemicals U.S.A., Inc.	EJT	Class II	2003-01-21
K023131	Freelite Human Lambda Free Kit	The Binding Site	DEH	Class II	2003-01-21
K023009	Freelite Human Kappa and Human Lambda Free Kits for Use on the Hitachi 911/912 Analyzer	The Binding Site	DFH	Class II	2003-01-21
K022170	Inner-Lock Locking Introducer Sheaths	Rex Medical LP	DYB	Class II	2003-01-21
K021176	Compumedics Somte System	Compumedics Limited	MNR	Class II	2003-01-21
K013884	Boussignac c.p.a.p. Device	Vygon SA	BYE	Class II	2003-01-21
K010714	Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830	Medi-Globe GmbH	FGE	Class II	2003-01-21
K030088	Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls	Biosite Incorporated	JJY	Class I	2003-01-17
K030067	Vitros Immunodiagnostic Products Hbsag Controls	Ortho-Clinical Diagnostics, Inc.	MJX	Class I	2003-01-17
K030028	Cpc by Soring Gmbh	Soring GmbH Medizintechnik	GEI	Class II	2003-01-17
K030012	Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372	Siemens Healthcare Diagnostics Inc.	JHX	Class II	2003-01-17
K024366	Coalescent Surgical U-Clip and Accessories	Coalescent Surgical	FZP	Class II	2003-01-17
K024236	Ultrasound Scanner, Type 2400	BK Medical ApS	IYN	Class II	2003-01-17
K024232	Liquichek Anti-Ss-B Control, Positive, Catalog #113	Bio-Rad	LKJ	Class II	2003-01-17
K024220	Liquichek Autoimmune Negative Control, Catalog #130	Bio-Rad	DHN	Class II	2003-01-17
K024218	Liquichek Anti-Ss-a Control, Positive, Catalog #114	Bio-Rad	LKJ	Class II	2003-01-17
K024056	Sureset 3.0 Ml Reservoir, Model 24-103	Applied Diabetes Research, Incorporated	FRN	Class II	2003-01-17
K024020	Theralight Uv120-2 Uva/uvb Phototherapy System	Theralight, LLC	FTC	Class II	2003-01-17
K024018	Avant Guardian 101	Avant Medical Corporation	KZE	Class II	2003-01-17
K023892	Millex Vv, Gv, and Hv Syringe Filter Units	EMD Millipore Corporation	BSN	Class II	2003-01-17
K023813	Bipolar Forceps	Richard Wolf Medical Instruments Corp.	GEI	Class II	2003-01-17
K023748	Flash-Lite II LED Dental Curing Light	Discus Dental LLC	EBZ	Class II	2003-01-17
K023745	Sechrist Air/oxygen Mixer, Model 3500 Cp-G	Sechrist Industries Inc	DTX	Class II	2003-01-17
K023742	Sculpture Plus Nano-Hybrid Composite	Pentron Laboratory Technologies	EBF	Class II	2003-01-17
K023739	Glucose-Sl-C Assay, Model 257-30	Sekisui Diagnostics P.E.I. Inc.	CFR	Class II	2003-01-17
K023710	Visorb Swift	Cp Medical	GAM	Class II	2003-01-17
K023689	Cg-500 Pmp Personal Medical Phone System	Card Guard Scientific Survival, Ltd.	DXH	Class II	2003-01-17
K023653	Maxone IV Fluid/blood Warmer, Model 102	Automatic Medical Technologies, Inc.	LGZ	Class II	2003-01-17
K023649	Vitique System	Dmg USA, Inc.	EMA	Class II	2003-01-17
K023609	Silverlon Adhesive Strip	Argentum International, LLC	FRO	Unclassified	2003-01-17
K023580	Sterngold Acid Etch Dental Implant System	Sterngold	DZE	Class II	2003-01-17
K023546	Maxim Accel Knee System	Zimmer GmbH	JWH	Class II	2003-01-17
K023535	Tripter X-1 Compact Duet	Direx Systems Corp.	LNS	Class II	2003-01-17
K023533	Barco Medis 5Mp2 Aura	Barco N.V.	LLZ	Class II	2003-01-17
K023531	Lesser Metatarsal Phalangeal Joint Implant	Nexa Orthopedics, Inc.	KWH	Class II	2003-01-17
K023528	Natural-Knee II Cemented Modular Tibial Baseplate	Centerplus Orthopedics, Inc.	JWH	Class II	2003-01-17
K023138	Hydrofera Bacteriostatic Wound Dressing	Hydrofera, LLC.	FRO	Unclassified	2003-01-17
K022035	Osteomedics Resorbable Small Fixation System, Osteosorb	Osteomedics, Inc.	JEY	Class II	2003-01-17
K024264	Skintact	Leonhard Lang GmbH	DRX	Class II	2003-01-16
K024247	Skintact ECG Electrodes with Kl 02 Liquid Gel	Leonhard Lang GmbH	DRX	Class II	2003-01-16
K024200	Innova 2000 and Innova 2000S (Mobile Version)	GE Healthcare	OWB	Class II	2003-01-16
K023952	Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite	Nobel Biocare Uas, Inc.	DZE	Class II	2003-01-16
K023920	Skintact	Leonhard Lang GmbH	DRX	Class II	2003-01-16
K023727	Temporary Cement-Dc010002	GC America Inc.	EMA	Class II	2003-01-16
K023682	Enclose Anastomosis Assist Device	Novare Surgical Systems, Inc.	DXC	Class II	2003-01-16
K023544	Genzyme Contrast II Hcg Urine/serum Test	Genzyme Corporation	JHI	Class II	2003-01-16
K023519	Radionics Varilink 2	Radionics, A Division of Tyco Healthcare Group LP	IYE	Class II	2003-01-16
K023515	Pre-Powdered Latex Surgeon's Gloves	Sanrea Healthcare Private Limited	KGO	Class I	2003-01-16