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 |
|---|---|---|---|---|---|
| K001637 | Disposable Powder Free Nitrile Exam Glove, Green Color | Sheen More Ent. Co., Ltd. | LZA | Class I | |
| K001601 | Disposable PVC Powdered Synthetic Exam Gloves | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | |
| K001482 | Aurenorm 75 Kf | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001481 | Palceram 49 | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001299 | Plain and Chromic Gut Absorbable Surgical Sutures Usp | Cp Medical | GAL | Class II | |
| K001277 | Triflange Acetabular Cup System | Depuy Orthopaedics Inc. | LPH | Class II | |
| K001274 | Latex Surgeon Surgeon's Gloves Powder-Free with Protein Content Labeling Claim (50 Micrograms or Less) | P.T. Maja Agung Latexindo | KGO | Class I | |
| K001223 | Aculux, Model Ax3001, Ax3002 | Aculux | FQP | Class II | |
| K001185 | Polypropylene, Nonabsorbable Surgical Sutures Usp | Cp Medical | GAW | Class II | |
| K001184 | Silk, Nonabsorbable, Surgical Sutures, Usp | Cp Medical | GAP | Class II | |
| K001173 | Nylon, Nonabsorbable Surgical Sutures Usp | Cp Medical | GAR | Class II | |
| K001172 | Polyester Nonabsorbable Surgical Sutures Urp | Cp Medical | GAT | Class II | |
| K001142 | Audio Technologies S:r.1 | Audio Technologies S.r.l. | ETB | Class II | |
| K001107 | Fresenius Combilines Low Volume Blood Tubing Set, Models 03-2291 (Post Pump) and 03-2292 (Pre-Pump) | Fresenius Medical Care Renal Therapies Group, LLC | FJK | Class II | |
| K001078 | Sulzer Orthopedics Ms-30 Femoral Stem | Sulzer Orthopedics, Inc. | JDI | Class II | |
| K000990 | Opus 10 Dental Diode Laser | Opusdent, Ltd. | GEX | Class II | |
| K000906 | Klinidrape Surgical Drapes | Molnlycke Health Care | KKX | Class II | |
| K000827 | Unicompartmental Patellofemoral Prosthesis (Upp) Cemented | Walter Abendschein, M.D. | KRR | Class II | |
| K000351 | Hanwella Latex Patient Exam. Gloves Powder-Free | Hanwella Rubber Products, Ltd. | LYY | Class I | |
| K000278 | Vivant Medical Biopsy Marker System | Vivant Medical, Inc. | FZP | Class II | |
| K994393 | Aequalis Universal Shoulder Glenoid | TORNIER Inc. | KWS | Class II | |
| K994384 | Clicker | Bioject, Inc. | KZE | Class II | |
| K991038 | Vaso Press Dvt System, Models Vp500, Vp501 | Britt Corp., Inc. | JOW | Class II | |
| K990209 | Novac7 | Hitesys S.p.A. | IYE | Class II | |
| K001439 | Orthoceph Oc100 D | Instrumentarium Corp. | MUH | Class II | |
| K001215 | Dbest Hcg 2 Iu/ml Test Kit | Ameritek, Inc. | JHI | Class II | |
| K001088 | Ultrasim CT System | Philips North America LLC | JAK | Class II | |
| K001066 | Cd Horizon Eclipse | Medtronic Sofamor Danek | MNH | Class II | |
| K000994 | BIPAP Duet Lx Bi-Level System | Respironics, Inc. | BZD | Class II | |
| K000978 | Anatomic Total Knee Prosthesis | Zimmer GmbH | JWH | Class II | |
| K000959 | Criterion 60 or Pm 60 | Caradyne, Ltd. | CAP | Class II | |
| K994410 | Instant-View Marijuana (Thc) Urine Dip Strip Test | Alfa Scientific Designs, Inc. | LDJ | Class II | |
| K992606 | Canon Laser Blood Flowmeter (Clbf) Model 100 | Canon Medical Components U.S.A., Inc. | HLI | Class II | |
| K001786 | Temporary Gingival Cuff and Impression Post and Implant Analog | Sulzer Calcitek, Inc. | DZE | Class II | |
| K001769 | Vitros Chemistry Products Crea Dt Slides; Vitros Chemistry Products Dt Calibrator Kit | Ortho-Clinical Diagnostics, Inc. | CGX | Class II | |
| K001718 | Millennia Acupuncture Needle | united pacific Company | MQX | Class II | |
| K001629 | Disetronic Multifuse Infusion Pump System | Disetronic Medical Systems | FRN | Class II | |
| K001480 | Aurecast 40 B | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001479 | Palceram 53 | Aurex SA (Pty), Ltd. | EJT | Class II | |
| K001269 | Dentalmatic Ti Prosthesis and Dentalmatic Ti-a Prosthetic | Dentalmatic Technologies, Inc. | EJH | Class II | |
| K001240 | Seragard Injection Patch | Platinum Services, Inc. | KGX | Class I | |
| K001219 | Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System | Biomedical Ent., Inc. | JEY | Class II | |
| K001064 | Behring Coagulation Timer Analyzer (Bct) | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K993625 | Insufflation Needle- 120Mm, Model 900-200 | Genicon, LC | HIF | Class II | |
| K993176 | Multi-Racial Reference Population for Pdexa and Discovery | Norland Medical Systems, Inc. | KGI | Class II | |
| K993125 | Safetytip Multi-Sample Needle, Safetytip Blood Collection System | Safety Medical Supply Int,., Inc. | FMI | Class II | |
| K992935 | Ocd2001 | Contemporary Products, Inc. | NFB | Class II | |
| K991334 | Medi-Cult Hyaluronidase; | Medicult A/S | MQL | Class II | |
| K991331 | Medi-Cult M3 Medium | Medicult A/S | MQL | Class II | |
| K001733 | Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series | Zimmer GmbH | JDI | Class II |