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 |
|---|---|---|---|---|---|
| K030654 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions LLC | GEX | Class II | |
| K024057 | Curad Scar Therapy | Beiersdorf, Inc. | MDA | Class I | |
| K023898 | Gyne Ideas Minitape Rp Device | Gyne Ideas, Ltd. | PAH | Class II | |
| K023591 | Ultra High Pressure Injector Lines | DeRoyal Industries, Inc. | DQO | Class II | |
| K023335 | Qcs Her2 Immunocontrols (Product No. C010) | Qc Sciences, LLC | NJW | Class II | |
| K023030 | Demetech Polyester Nonabsorbable Suture | Demetech Corp. | GAT | Class II | |
| K023028 | Demetech Nylon Nonabsorbable Suture | Demetech Corp. | GAR | Class II | |
| K031705 | Skylight Imaging System | Philips North America LLC | KPS | Class II | |
| K031696 | Lorenze External Mandibular Distractor | Biomet Microfixation | MQN | Class II | |
| K031535 | Philips Easydiagnost Eleva | Philips North America LLC | KPR | Class II | |
| K031409 | Urinary Catheters | Promedic, Inc. | GBM | Class II | |
| K031384 | Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color, Examination Gloves (Intacta Polyurethane G | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K031326 | Imagine Reflex | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K031271 | One-Step Pregnancy Test | Amerisource Pharmacal, Inc. | LCX | Class II | |
| K030948 | Vmate Model Vmm1000 | Howard Instruments, Inc. | HQE | Class II | |
| K030891 | Surgistar Microkeratome Blade, Model No. 2400-Lsk | Surgistar, Inc. | HNO | Class I | |
| K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the Bd Paradigm Link Glucose Meter | Minimed, Inc. | LZG | Class II | |
| K030528 | Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/dl) | Clinical Data, Inc. | JIY | Class I | |
| K030099 | Baxter Arena Hemodialysis Delivery System, Model 1571278000 | Baxter Healthcare Corporation | KDI | Class II | |
| K023726 | TENS Pro 900 | Acumed Medical Supplies, Ltd. | GZJ | Class II | |
| K023666 | Rusch Guided Cholangiography Catheter | Rusch Intl. | FGE | Class II | |
| K031583 | Modification to Ivs Introducer Set, Model 1003 | Integrated Vascular Systems, Inc. | DYB | Class II | |
| K031197 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | Cordis US Corp. | FGE | Class II | |
| K031101 | Raichem Assayed Control Serum Level 1 & 2 | Hemagen Diagnostics, Inc. | JJY | Class I | |
| K031048 | Carestart Hcg Combo One-Step Pregnancy Test and Carestart Plus Hcg Combo One-Step Pregnancy Test | Access Bio Incorporate | JHI | Class II | |
| K030950 | Vidas Troponin I (Tni), Model 30 445 | bioMerieux, Inc. | MMI | Class II | |
| K030020 | Hemosplit Long-Term Hemodialysis Catheter | C.R. Bard Inc | MSD | Class II | |
| DEN030002 | Endotoxin Activity Assay (Eaa) Device | Spectral Diagnostics, Inc. | NGS | Class II | |
| K031533 | Vantage Anterior Fixation System | Medtronic Sofamor Danek | KWP | Class II | |
| K031205 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K031058 | Cord Stick Multiple Draw System | Cord Stick Corp. | FMI | Class II | |
| K031052 | Carestart Hcg One-Step Pregnancy Test | Access Bio Incorporate | DHA | Class II | |
| K031021 | Chlorinated, Polymer Coated, Powder-Free Latex Examination Glove | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K030887 | Lektrogel, Model Lk3001 | Inmed Ltda. | GYB | Class II | |
| K030844 | Final Varnish Lc | Voco GmbH | KLE | Class II | |
| K030211 | Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016 | Icn Biomedicals, Inc. | DKX | Class II | |
| K023881 | Profile 1064 Laser System | Sciton, Inc. | GEX | Class II | |
| K031264 | Porta Pressover | Wieland Dental + Technik GmbH & Co. KG | EJT | Class II | |
| K031103 | Pasco Mic and Mic/id Panels (Ertapenem) | Pasco Laboratories, Inc. | JWY | Class II | |
| K031083 | Opus Magnum Implant System, Model Om-1500 | Opus Medical, Inc. | HTY | Class II | |
| K030994 | Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves with & without Orange/vanilla Scents | Sgmp Co., Ltd. | LYY | Class I | |
| K030993 | Non-Sterile Powdered Green Colored Powdered Latex Patient Examination Gloves with & without Sour/apple/peppermint Scents | Sgmp Co., Ltd. | LYY | Class I | |
| K030987 | Contact Lens Storage Case | Pelican Products | LRX | Class II | |
| K030861 | Ha Pmi Flanged Acetabular Component | Zimmer GmbH | LPH | Class II | |
| K030608 | Oti Bone Cement Plug | Osteoimplant Technology, Inc. | JDK | Class II | |
| K030197 | Blackstone Posterior Cervical System | Blackstone Medical, Inc. | KWP | Class II | |
| K023670 | Single Use Oral Mask, Model Hc455a | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K031633 | Canon Inc., Digital Radiography, Model Cxdi-40C | Canon Medical Components U.S.A., Inc. | MQB | Class II | |
| K031627 | Nano-Ticrown | Nano-Write Corp. | EJH | Class II |