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 |
|---|---|---|---|---|---|
| K910232 | Hemagen Ena Screening Kit | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K910052 | Milenia Beta-2 Microglobulin | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K905865 | Anti-for Surgical Face Mask | Anago, Inc. | FXX | Class II | |
| K905816 | Orthovision Table | American Sterilizer Co. | JEB | Class I | |
| K905766 | Drainage Tube Restraint/wound Cover | M. Imonti and Associates Inc. | GBX | Class I | |
| K905759 | Hasson Stabilizing Access Cannula for Open Laparos | Marlo Surgical Technology | HET | Class II | |
| K905695 | Micro-X 80Hf | Fischer Imaging Corp. | IZO | Class I | |
| K905648 | Crp Lipid Reagent Test Pack | Cirrus Diagnostics, Inc. | CHH | Class I | |
| K905519 | Montrose Dressing Applicators | Olemunda Pty, Ltd. | NAD | Class I | |
| K905367 | E-20 Rapid Cuff Inflator | D. E. Hokanson, Inc. | DXN | Class II | |
| K905181 | No Profile Olbert Catheter System for Urology | Meadox Surgimed, Inc. | EZN | Class II | |
| K905136 | Gauze Sponges, Internal and External | American Healthcare Corp. | EFQ | Unclassified | |
| K905135 | Laparotomy Sponges | American Healthcare Corp. | GDY | Class I | |
| K904881 | Disposable Yankauer Suction Tube | Pilling Medical S.A. | GEA | Class I | |
| K904869 | Ellipse Punch | Kramer Const | LRY | Class I | |
| K904785 | Cri Cynosar Catheter | Catheter Research C/O Burditt, Bowles & Radzius | DRA | Class II | |
| K904445 | Omiband | Omikron Scientific, Ltd. | KGX | Class I | |
| K904265 | Inamed Ruiz-Cohen Intraoperative Tissue Expander | Inamed Development Co. | FZW | Class I | |
| K904233 | Convatec Absorbent Bandage | Convatec, A Division of E.R. Squibb & Sons | EXE | Class I | |
| K903339 | Video Endoscope, Rigid | Medical Dynamics, Inc. | HET | Class II | |
| K902936 | Polyurethane Condom | Apex Medical Technologies, Inc. | HIS | Class II | |
| K910752 | Fortress Liberty Manual Folding Wheelchair | Fortress Litestyle | IOR | Class I | |
| K910750 | Fortress Custom Manual Folding Wheelchair | Fortress Litestyle | IOR | Class I | |
| K910748 | Fortress Edge Manual Rigid Wheelchair | Fortress Litestyle | IOR | Class I | |
| K910746 | Fortress Freestyle II Manual Folding Wheelchair | Fortress Litestyle | IOR | Class I | |
| K910517 | Cap System Rast Asm/ria and Asm/feia | Pharmacia, Inc. | DHB | Class II | |
| K910274 | Artiflex(tm) | Beiersdorf, Inc. | LGF | Class I | |
| K910242 | Ef Synergy Quad Modified | Remel Inc | JWY | Class II | |
| K910135 | The Universal Cement Plug(tm) | Biotron, Ltd. | LZN | Class II | |
| K905640 | Solid Core Gutta Percha Carrier | The Hygenic Company, LLC | EKS | Class I | |
| K905511 | Codman Neurolase Laser System/modification | I.L. Med, Inc. | GEX | Class II | |
| K905461 | Procedure Kit/routine Dental Procedures | Angiosystems, Inc. | EKS | Class I | |
| K905453 | Crystal Focus Emerald Laser/slt Ophf 0.6 Endo Hand | Douglas James Donaldson Compliance Services | HQF | Class II | |
| K905451 | System Ten, Model 100 Surgery Syst/orthopaedic Use | Advanced Osseous Technologies | JDX | Class II | |
| K905414 | Mangar Booster | Northfleet Management Group, Inc. | FNG | Class II | |
| K905264 | Stat Profile 8 Analyzer,calibrators and Materials | Nova Biomedical Corporation | JGS | Class II | |
| K904797 | Surgitek Graduated Cystoscope (Model Gc-16) | Surgitek | FBO | Class II | |
| K904793 | Surgitek Graduated Ureteroscope (Model Gu-8) | Surgitek | FGB | Class II | |
| K904396 | Simplex Neonatal Breathing Circuit System | Simplex Medical Systems, Inc. | BZQ | Class II | |
| K904359 | Esi-3000 Ultrasound System | Elscint, Inc. | IYN | Class II | |
| K903838 | Optilase (Tm) Model 900 Argon | Trimedyne, Inc. | GEX | Class II | |
| K903561 | Quick-Clip Needle Guide | Acuson Corp. | ITX | Class II | |
| K903526 | Alta(r) Pfx Im Rod | Howmedica Corp. | HSB | Class II | |
| K902197 | Fujinon Evl-F (Tentative) and Trocar | FUJIFILM Healthcare Americas Corporation | HET | Class II | |
| K910612 | Candela Diode Trabeculoplasty Laser Dtl | Candela Corporation | HQF | Class II | |
| K910506 | Ofloxacin, 5 Mcg Sensi-Disc | BD Becton Dickinson Vacutainer Systems Preanalytic | JTN | Class II | |
| K910252 | Potocky Neddle (Tm) Disposable Injection Needle | CooperSurgical, Inc. | HEE | Class II | |
| K910182 | 3M Brand Ear Loop Face Mask, 2000F | 3M Company | FXX | Class II | |
| K910108 | Gds Enzymatic B-Hydroxybutyrate Reagent Modified | Gds Diagnostics | JIN | Class I | |
| K905781 | Apr and Apr II Press-Fit Universal Hip System | Intermedics Orthopedics | MEH | Class II |