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 , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| 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 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K903538 | Wiron 99 Dental Casting Alloy | Leach and Dillon Co., Inc. | EJH | Class II | |
| K902193 | Kevtek Laser-Stop Endotracheal Tube Laser-Stop | Kevtek Medical Products, Inc. | BTR | Class II | |
| K910527 | Emit Convenience Pack for the Cobas Mira Primidone | Syva Co. | DJD | Class II | |
| K910127 | Sunglasses, Non-Prescription (Polinelli) | The Limited Stores, Inc. | HQY | Class I | |
| K910126 | Sunglasses, Non-Prescription (Italo Cremona) | The Limited Stores, Inc. | HQY | Class I | |
| K910125 | Sunglasses/non-Prescription (La Giardiniera) | The Limited Stores, Inc. | HQY | Class I | |
| K905864 | Sunglasses (Non-Prescription) | The Limited Stores, Inc. | HQY | Class I | |
| K905750 | Lacrimal Plug | Tamcenan Corp. | LZU | Unclassified | |
| K905722 | Suture Applier Device | Laparomed Corp. | MFJ | Class II | |
| K905605 | Force 10, 20, 30, and 40 | Medtronic, Inc. | GEI | Class II | |
| K905595 | Ace Reconstructive Plate | Ace Medical | HRS | Class II | |
| K905482 | Bondek Polyglycolic Acid Synthetic Absorb. Suture | Pfizer Hospital Products Group, Inc. | GAM | Class II | |
| K903563 | Howmedica Hnr System | Howmedica Corp. | LWJ | Class II | |
| K902296 | Trabeculo-Suprachoroidal Shunt | Visionex, Inc. | KYF | Class II | |
| K910690 | 3M Model 8240 Ite Hearing Aid | 3M Company | ESD | Class I | |
| K910335 | Mtp Transport Infusion Pump, Model No. Mtplea | Medical Technical Products, Inc | FRN | Class II | |
| K910202 | Dentronix Model 2000 | Dentronix, Inc. | KMH | Class II | |
| K910005 | Vital-Port(tm) m.r.i. Vascular Access System | Med Institute, Inc. | LJT | Class II | |
| K905630 | Infant Reflux Sling | Pedicraft, Inc. | FRP | Class I | |
| K905629 | Pedicraft Infant Reflux Wedge | Pedicraft, Inc. | FRP | Class I | |
| K905491 | Microline Screen for Opiates | Drug Screening Systems, Inc. | DJG | Class II | |
| K905381 | Manhandler | Lifeport, LLC. | FPP | Class I | |
| K905289 | Surgitek(r) Lubri-Flex(tm) Ureteral Stent | Medical Engineering Corp. | FAD | Class II | |
| K903223 | On-Site Alcohol | Toxi-Lab, Inc. | DOJ | Class II | |
| K903034 | Renalyzer Prx 90 | Swedish Trade Council USA | CGL | Class II | |
| K910723 | Biodegradable Surgical Staple | Instrument Makar, Inc. | JDR | Class II | |
| K910329 | Sunglasses | Cutler & Gross Sloan Optical, Ltd. | HOI | Class I | |
| K910138 | Tvs II Electronic Incentive Spirometer | Monaghan Medical Corp. | BWF | Class II | |
| K910082 | Positive Control Pad for Total Ige Test Dipstick | Ortho-Clinical Diagnostics, Inc. | DGC | Class II | |
| K910010 | Q System 28 Hip Stem | Turnkey Intergration USA, Inc. | LWJ | Class II | |
| K905770 | Ciba Corning Acs Ferritin Immunoassay | Ciba Corning Diagnostics Corp. | DBF | Class II | |
| K905764 | Seminor | Promedex, Inc. | MFD | Class II | |
| K905607 | Kodak X-Omat Multiloader 300 | Eastman Kodak Company | IXW | Class II | |
| K905606 | External Fetal Monitor Transducer Holder | Atheus Corp. | HGM | Class II | |
| K905580 | Total Shoulder Prosthesis Polyethylene Glenoind Co | Exactech, Inc. | HSD | Class II | |
| K905577 | Exactech Humeral Shoulder Prosthesis | Exactech, Inc. | HSD | Class II | |
| K905572 | Edlich Wound Management Tray | Sorex Medical | MCY | Class II | |
| K905256 | Next Wave(r) Physioaccoustic(tm) Chair | Next Wave, Inc. | IOR | Class I | |
| K905179 | Syva Microtrak Chlamlydia Eia, Modification | Syva Co. | LJC | Class I | |
| K904633 | Spiroloop, Modification | Pneumedics, Inc. | CCJ | Class II | |
| K904329 | Clostridium Difficile Toxin a Enzyme Immunoassay | Baxter Healthcare Corporation | MCB | Class I | |
| K903505 | Bact/alert (Tm) | bioMerieux, Inc. | MDB | Class I | |
| K903498 | Retainer, Screw Expansion Orthodontic | Masel Industries, Inc. | EJF | Class I | |
| K902766 | Advanced Ischemica Recorders Model 2000 Cassette | Advanced Ischemia Recorders, Inc. | DSH | Class II | |
| K902449 | Sterile Surgeon's Gloves | Unigloves, Ltd. | KGO | Class I | |
| K910891 | PVC Vinyl Glove | Pioneer Sundries Products, Ltd. | LYZ | Class I | |
| K910835 | Bactec Nr-860 | BD Becton Dickinson Vacutainer Systems Preanalytic | JTA | Class I | |
| K910756 | Abuscreen(r) Fp for Methamphetamine (500-1000) | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K910689 | Abuscreen(r) Online Controls | Roche Diagnostic Systems, Inc. | LAS | Class I | |
| K910638 | Systemate Triglyceriides (Epos Application) #65477 | Em Diagnostic Systems, Inc. | CDT | Class I |