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 |
|---|---|---|---|---|---|
| K021669 | Physician's Desktop Review | Philips North America LLC | LLZ | Class II | |
| K021621 | Fixed Bearing Uni Component | Zimmer GmbH | HRY | Class II | |
| K021584 | Replace Scalloped Margin Implant System | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K021559 | Ascent All-Poly Ps Tibial Bearings | Zimmer GmbH | JWH | Class II | |
| K021260 | Reduced Size Oncology Salvage System | Zimmer GmbH | KRO | Class II | |
| K020969 | Vacurect Vacuum Constriction Device | Vacurect Manufacturing (Pty), Ltd. | LKY | Class II | |
| K020889 | Endoscopic Light Source Xl202/l3 | World of Medicine Lemke GmbH | GCT | Class II | |
| K020779 | Proximate and Endopath Linear Cutters and Staplers | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K020772 | Omega II System | Howmedica Osteonics Corp | KTT | Class II | |
| K013902 | U-Systems Diagnostic Ultrasound System Usi-2000 | U-Systems, Inc. | IYN | Class II | |
| K013654 | Precision Systems Analette Chemistry Analyzer | Precision Systems, Inc. | JJF | Class I | |
| K021700 | Animus Ezserter Infusion Set Inserter | Animas Corp. | KZH | Class II | |
| K021420 | Paracon Ii/fecal Concentrator II | Para Scientific Co. | LKS | Class I | |
| K021295 | Saview Toric 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear | St. Shine Optical Co., Ltd. | LPL | Class II | |
| K020855 | Igel 55Uv (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,igel 55 UV Multifocal (Methafilcon a) Soft | Igel Vision Care Pte, Ltd. | LPL | Class II | |
| K020741 | Unicondylar Knee | Encore Orthopedics, Inc. | HRY | Class II | |
| K020729 | Nlite System,model A00-1051 | Icn Photonics, Ltd. | GEX | Class II | |
| K020487 | Careside Alt | Careside, Inc. | CKA | Class I | |
| K020395 | Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit) | Lin-Zhi International Inc | DKZ | Class II | |
| K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | MVN | Class II | |
| K020368 | Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit) | Lin-Zhi International Inc | DJG | Class II | |
| K020364 | Phoenix Ise Reagents for Beckman Cx Systems | Phoenix Diagnostics, Inc. | JGS | Class II | |
| K013321 | Silicone Tracheal T-Tubes | Technical Products, Inc. | BTR | Class II | |
| K013213 | Hyperion Visiquant Ana Test Kit | Hyperion, Inc. | DHN | Class II | |
| K013032 | Physiolog, Series 95000 | Camtronics, Ltd. | DQK | Class II | |
| K010132 | Klockner Dental Implants, Models Sk, Nk, Ik, S3, and S4 | Soadco, S.L. | DZE | Class II | |
| K021448 | Modification to Accu-Chek Active System | Roche Diagnostics GmbH | NBW | Class II | |
| K021257 | Ana Line Blot, Catalog Number: Kalabi (20 Tests) | Siemens Healthcare Diagnostics Inc. | LKJ | Class II | |
| K021129 | Chare Cariovascular Patch | Chase Medical, Inc. | DXZ | Class II | |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3Kg100 | Scantibodies Laboratory Inc. | CKG | Class II | |
| K020938 | Microscan Microstrep Plus Panel-Meropenem | Dade Microscan, Inc. | JWY | Class II | |
| K020900 | Devilbiss Model 9200D Heated Humidifier System | Sunrise Medical Hhg, Inc. | BTT | Class II | |
| K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117 | BIOTRONIK AG | DQX | Class II | |
| K020776 | Medoral Hygienic Toothbrush with Dentosan Filaments | Coronet Group North America, LLC | EFW | Class I | |
| K020764 | Navipro | Kinamed Inc | HAW | Class II | |
| K020739 | Bci 3178 Pediatric Pulse Oximetry Sensor | Bci, Inc. | DQA | Class II | |
| K020736 | Traatek Cottonoid Patties | Traatek, Inc. | HBA | Class II | |
| K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-Sterile | Precision Dynamics Corporation | HFW | Class II | |
| K020711 | Wallach Loop Electrode | CooperSurgical, Inc. | GEI | Class II | |
| K014247 | Triage Drugs of Abuse Panel Plus Ppx, Model Catalog 92002 | Biosite Incorporated | DKZ | Class II | |
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models | Altus Medical, Inc. | GEX | Class II | |
| K013733 | System 100; S-100 Ultrafiltration Console; Bdt 500 Ultrafiltration Set | Chf Solutions, Inc. | KDI | Class II | |
| K012667 | Reprocessed Arthroscopic Shapers | Surgical Instruments Service and Savings, Inc. | HRX | Class II | |
| K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K021606 | En-Snare Endovascular Snare and Catheter | Medical Device Technologies, Inc. | MMX | Class II | |
| K021563 | Intracoil Self-Expanding Peripheral Stent | Sulzer Intratherapeutics, Inc. | JCT | Class II | |
| K021531 | Rpi Replacement Phototherapy Lights | Replacement Parts Industries, Inc. | LBI | Class II | |
| K021403 | Ha Mallory/head Porous Femoral Stem & Ha Mallory/head Porous Lateralized Femoral Stem | Biomet Orthopedics, Inc. | MEH | Class II | |
| K021379 | Scs Claris Spinal System, Lengthened Lateral Connector, Model Al06 | Ortho Tec, LLC | MNI | Class II | |
| K021000 | Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Gloves | Shanghai Glovmax Enterprise Co.,Ltd | LZA | Class I |