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 1415 of 3531

510(k) clearances, page 1415 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032692	Dakocytomation Beta-2-Microglobulin Kit, Code No. Oa 368	Dako A/S	JZG	Class II	2004-01-22
K032101	Powerstand Stand-Up Wheelchair	The Standing Company	IPL	Class II	2004-01-22
K031841	Spacer G Temporary Hip Prosthesis	Exactech, Inc.	KWL	Class II	2004-01-22
K031621	Hero 1, Model Ly-Esb220	Comfort Orthopedic Co., Ltd.	IPL	Class II	2004-01-22
K030876	Cynosure Triactive Therapeutic Massage System	Cynosure, LLC	ISA	Class I	2004-01-22
K024252	Match Master Low Fusion Porcelain	Davis Schottlander & Davis, Ltd.	EIH	Class II	2004-01-22
K022908	Posterior Cable Screw	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MNI	Class II	2004-01-22
K040015	Modification to Prismalix Surgical Light	Alm S.A.	FSY	Class II	2004-01-21
K034055	Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin I	Siemens Healthcare Diagnostics Inc.	JHX	Class II	2004-01-21
K034040	Esprit Ventilator, Model V1000	Respironics, Inc.	CBK	Class II	2004-01-21
K034031	10 Ml Bak'snap Duopross Retractable Safety Syringe	MK Meditech	MEG	Class II	2004-01-21
K034020	Groshong Nxt Picc Catheters	C.R. Bard Inc	LJS	Class II	2004-01-21
K034019	Poly per-Q-Cath Picc Catheters	C.R. Bard Inc	LJS	Class II	2004-01-21
K033865	Ideia Pce Chlamydia	Dakocytomation, Ltd.	LJC	Class I	2004-01-21
K033632	Variflex	Great Lakes Orthodontics, Ltd.	EBI	Class II	2004-01-21
K033409	Amersham Health Needle-Guard	Gettig Pharmaceutical Instrument Co.	FMI	Class II	2004-01-21
K033176	Tristar Aesthetic Workstation Laser	Cynosure, LLC	GEX	Class II	2004-01-21
K032511	Intuition Image	Brainlab, Inc.	LHN	Class II	2004-01-21
K031860	Sk Med Me202 Monitoring Mixer	Sk Med	BZR	Class II	2004-01-21
K031686	Aeromist Lt, Model Hcs15004	MEDLINE INDUSTRIES, LP - Northfield	BTI	Class II	2004-01-21
K031321	Liquishield Liquid Bandage, Model Lsb 0001	Medlogic Global Limited	KMF	Class I	2004-01-21
DEN040001	Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System	Advanced Diagnostic Systems	NQI	Class II	2004-01-21
K040018	Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412	Boston Scientific Corporation	EOQ	Class II	2004-01-20
K033956	Mobile Single Circular Camera (Msc) & Mobile Digital Cardiac Camera (Mdcc)	Is2 Research, Inc.	KPS	Class II	2004-01-20
K033902	Ontrak Testcup II and Onsite Cupkit	Varian, Inc.	DKZ	Class II	2004-01-20
K033744	Autostat II Anti-Tisue Transglutaminase Iga Elisa	Hycor Biomedical	MVM	Class II	2004-01-20
K033507	Mrj	Paramed S.r.l.	LNH	Class II	2004-01-20
K033476	Modification to Hoffmann II Micro External Fixation System	Howmedica Osteonics Corp	KTT	Class II	2004-01-20
K033437	Sphinx Laser Systems	Allmed Systems, Inc.	GEX	Class II	2004-01-20
K032799	Non-Contact Tonometers, Ocular Response Analyzer	Reichert, Inc.	HKX	Class II	2004-01-20
K032641	Modification to: the Margron Hip Replacement System	Portland Orthopaedics Pty., Ltd.	MEH	Class II	2004-01-20
K032604	Gii Spinal Fixation System	Co-Ligne AG	MNH	Class II	2004-01-20
K033915	Modification to Seraquest Eb Vca Igg	Quest Intl., Inc.	LSE	Class I	2004-01-16
K033904	Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)	Cook Incorporated	MQH	Class II	2004-01-16
K033903	Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes,	Cook Incorporated	MQH	Class II	2004-01-16
K033877	Disposable Powder Free Vinyl Synthetic Examination Glove, White Color	One Touch Products Co., Ltd.	LYZ	Class I	2004-01-16
K033726	Pvs Pivot Steerable Delivery System Microcatheter	Precision Vascular	KRA	Class II	2004-01-16
K033693	Powder-Free Vinyl Examination Gloves	Shen Wei (USA), Inc.	LYZ	Class I	2004-01-16
K033692	Powdered Vinyl Examination Gloves	Shen Wei (USA), Inc.	LYZ	Class I	2004-01-16
K033658	E.p.t. Pregnancy Test	Unipath, Ltd.	LCX	Class II	2004-01-16
K033628	Artic	Kulzer GmbH	ELM	Class II	2004-01-16
K033585	Diapex	Bisco Inc	KIF	Class II	2004-01-16
K033521	Bisblock	Bisco Inc	EJK	Class II	2004-01-16
K033461	Candela Vbeam Pulse Dye Laser System	Candela Corporation	GEX	Class II	2004-01-16
K033363	Zimmer Unicompartmental Knee System	Zimmer GmbH	HSX	Class II	2004-01-16
K033344	Ligand Plus Control Level 1-3	Consolidated Technology	JJY	Class I	2004-01-16
K033331	Candela Cbeam Pulse Dye Laser System	Candela Corporation	GEX	Class II	2004-01-16
K033328	Novosci Tubing and Connectors with Novocoat Treatment	Novosci Corp	DTL	Class II	2004-01-16
K033227	Luxaform Plus	Dmg USA, Inc.	EBG	Class II	2004-01-16
K032303	Stryker Consolidated Operating Room Equipment (Core) System	Stryker Corp.	HBE	Class II	2004-01-16