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 1544 of 3531

510(k) clearances, page 1544 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K011710	Oxoid Pbp2 1 Latex Agglutination Test	Oxoid, Ltd.	MYI	Class II	2002-04-02
K011510	Multi Hi-Flo Pneu, Wisap #7080	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HIF	Class II	2002-04-02
K020629	Simplicity Simplex Soft Infusion Set	Sterling Medivations, Inc.	FPA	Class II	2002-04-01
K013715	Re-Usable Sterilization Pouch / Bag	Quality Products of Montana	FRG	Class II	2002-04-01
K020973	Ex-308 Excimer Laser for Phototherapy Treatment of Vitiligo	Surgilight, Inc.	GEX	Class II	2002-03-29
K020898	D.sign 15 (Dw286 B)	Ivoclar Vivadent, Inc.	EJH	Class II	2002-03-29
K020871	Vitek 2 Antimircrobial Susceptibility Test System for Levofloxacin	bioMerieux, Inc.	LON	Class II	2002-03-29
K020702	O'regan Disposable Anoscope	Canadian Theatre Products, Ltd.	FER	Class II	2002-03-29
K020677	Gamma 3 Lag Screw	Howmedica Osteonics Corp	HSB	Class II	2002-03-29
K020659	Durex Latex Condom with Male Genital Desensitizer Lubricant	Ssl Americas, Inc.	HIS	Class II	2002-03-29
K020650	Modification to Reflex Anterior Cervical Plate System	Howmedica Osteonics Corp	KWQ	Class II	2002-03-29
K020467	Spife Ld Vis Isoenzyme Kit, Models 3450, 3451, and 3452	Helena Laboratories, Corp.	CFE	Class II	2002-03-29
K020267	Optilux Curing Lights	Sybron Dental Specialties, Inc.	EBZ	Class II	2002-03-29
K020006	Dyna Intra-Limbal Lens	Lens Dynamics, Inc.	HQD	Class II	2002-03-29
K014305	Resorbable Lactosorb-L Acl Crosspin	Arthrotek, Inc.	HTY	Class II	2002-03-29
K014302	Universal Multiaxis (Unimax) Pedicle Screw System	Pisharodi Surgicals, Inc.	MNH	Class II	2002-03-29
K013871	Lifeguard Safety Infusion Set	Boston Scientific Corporation	FPA	Class II	2002-03-29
K013779	Thermometer Models St8132c, St8132f, St8142c, St8142f, St8532c, St8532f, St8542c, and St8542f	Mesure Technology Co., Ltd.	FLL	Class II	2002-03-29
K020798	Hemochron Jr. Signature +	Accriva Diagnostics, Inc.	JPA	Class II	2002-03-28
K020669	Permanent Pacing Lead, Models Petite, Petite R, J, Rj, Petite B, Rb, Jb, Rjb	Oscor Inc.	DTB	Class III	2002-03-28
K020667	Codman Hakim Shunt Systems	Cerenovus, Inc.	JXG	Class II	2002-03-28
K020663	Modification to Sparc Sling System	American Medical Systems, Inc.	OTN	Class II	2002-03-28
K020622	Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power Cord; and Wands	ArthroCare Corporation	GEI	Class II	2002-03-28
K020621	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	ArthroCare Corporation	GEY	Class I	2002-03-28
K020490	Pbs, Pbsw with Cations and Phenol Red	Conception Technologies	MQL	Class II	2002-03-28
K020441	Emit II Plus Monoclonal Cocaine Metabolite Assay	Siemens Healthcare Diagnostics Inc.	DIO	Class II	2002-03-28
K020342	Unifil Flow	GC America Inc.	EBF	Class II	2002-03-28
K014290	Entec Plasma Wands	ArthroCare Corporation	GEI	Class II	2002-03-28
K014289	Orthoss Resorbable Bone Void Filler	Geistlich Pharma AG	LYC	Class II	2002-03-28
K013984	Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2kbr	Siemens Healthcare Diagnostics Inc.	MOI	Class II	2002-03-28
K013714	Codan US i.v. Administration Set, Model B400 Sp	Codan US Corp.	FPA	Class II	2002-03-28
K013551	Zeus Microwrist Robotic Surgical System	Computer Motion, Inc.	GCJ	Class II	2002-03-28
K012041	The Hammer Model H100	Tenacore Holdings, Inc.	DXC	Class II	2002-03-28
K011588	Suretone	Suretone International	IPF	Class II	2002-03-28
K020881	Modification to Personal Infusor Local Pain Management Procedural Kit	Science Incorporated	FRN	Class II	2002-03-27
K020806	Acs:180 & Advia Centaur Afp Immunoassay	Bayer Corp.	LOJ	Class II	2002-03-27
K020680	Prowler Select 10 and 14 Infusion Catheters with and without Pre-Shaped Tips	Cordis Neurovascular, Inc.	KRA	Class II	2002-03-27
K020611	Universal Bone Plate III System (Ubp III)	Spinal Concepts, Inc.	HRS	Class II	2002-03-27
K020322	Bd Phoenix Automated Microbiology System	Becton Dickinson & Co	LON	Class II	2002-03-27
K020269	Procera Allceram Bridge Material	Procera Sandvik, Inc.	EIH	Class II	2002-03-27
K020031	En-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302	Neothermia Corp.	GEI	Class II	2002-03-27
K014304	Bone-Lok Bioabsorbable Compression Anchor, Model Bmcd-35-3050S	Triage Medical, Inc.	HWC	Class II	2002-03-27
K014272	Periolase Nd:yag Dental Laser System	Millennium Dental Technologies, Inc.	GEX	Class II	2002-03-27
K014268	Norapad Plain; Norapad Ta	Perlei Medical, Inc.	HBA	Class II	2002-03-27
K014260	Tissuelink Solid Cylinder Monopolar Device	Medtronic Navigation, Inc	GEI	Class II	2002-03-27
K013949	Universal Vial Access Spike with Needleless Connector	Vygon Mfg	FPA	Class II	2002-03-27
K013931	Omni Oxygen System, Model 1000	Sequal Technologies, Inc.	CAW	Class II	2002-03-27
K013488	Sophy Pressure Adjustable Valve System Model Sm8	Sophysa	JXG	Class II	2002-03-27
K012994	Wizair Dvt	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2002-03-27
K012849	Glass Post	J. Morita USA, Inc.	ELR	Class I	2002-03-27