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 |
|---|---|---|---|---|---|
| K001253 | Surgitron Iec II | Ellman Intl., Inc. | GEI | Class II | |
| K001203 | Olympus Um 2R/3r Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract | Olympus Optical Co., Ltd. | ITX | Class II | |
| K000993 | Liberty 9000 Breast Coil | GE Healthcare Coils | MOS | Class II | |
| K000973 | Behring Coagulation System (Bcs) | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K000960 | Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900 | Barzell-Whitmore Maroon Bells, Inc. | IYO | Class II | |
| K000802 | Spiral Imaging Option | GE Healthcare | LNH | Class II | |
| K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology Corp. | HQD | Class II | |
| K000738 | Wheelchair, Models H001a, 4422 | Jackson Company, LLC | IOR | Class I | |
| K000673 | Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241 | Richard Wolf Medical Instruments Corp. | HIH | Class II | |
| K000669 | Medivision I-View Personal Video Display | Medivision Endoscopy | GCJ | Class II | |
| K000500 | Dinamap Advanced Nibp Module | Critikon Company, LLC | DXN | Class II | |
| K000215 | Swivel Elbow | Engineered Medical Systems, LLC | BZD | Class II | |
| K993877 | Nelson Water Systems for Hemodialysis | Nelson Environmental Technologies, Inc. | FIP | Class II | |
| K993777 | Disposable and Reusable Ball and Loop Electrodes | R-Group Intl. | HGI | Class II | |
| K993484 | Q-Htf, Cat# 2001 | Invitrocare Inc | MQL | Class II | |
| K992085 | Abbott Imx Glycated Hemoglobin II | Abbott Medical | LCP | Class II | |
| K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | Bio-Rad | JJY | Class I | |
| K000938 | Ivc One Medium | Invitrocare Inc | MQL | Class II | |
| K000937 | Ivc Two Medium | Invitrocare Inc | MQL | Class II | |
| K000686 | Krom-Alginate and Alginate Plus | Cavex Holland B.V. | ELW | Class II | |
| K000680 | Vision Esthetic Porcelain System | Midatlantic Division of Dentrex, Inc. | EIH | Class II | |
| K000639 | Visionary 2000 | Burton Medical Products Corp. | FSY | Class II | |
| K000633 | Synthetic Glass Bone Graft Material | Blue Sky Bio, LLC | LYC | Class II | |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40, 780-41, 780-42, 780-43 | Hudson Respiratory Care, Inc. | BTT | Class II | |
| K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems | JGY | Class I | |
| K001346 | Ultimum Hemostasis Introducer, Model 4076Xx | Abbott Medical | DYB | Class II | |
| K001256 | Control Plasma N | Siemens Healthcare Diagnostics Inc. | GIZ | Class II | |
| K001243 | Dornier Medilas H | Dornier Surgical Products, Inc. | GEX | Class II | |
| K001002 | Wako Lipase Calibrator | FUJIFILM Healthcare Americas Corporation | JIS | Class II | |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator Kits | Elan Holdings, Inc. | CDQ | Class II | |
| K000922 | Proton Vision | Varian Assoc., Inc. | MUJ | Class II | |
| K000645 | Ge Marquette Medical Systems Prucka Cardiolab Cath System, Version 1.11 | General Electric Medical Systems Information Techn | DPS | Class II | |
| K994426 | Glovetex, Latex Examination Gloves, Powdered Non-Sterile.(protein Content Labeling) | Pt. Wrp Buana Multicorpora | LYY | Class I | |
| K994350 | Neer III Total Shoulder System | Smith & Nephew, Inc. | KWS | Class II | |
| K994098 | Vinyl Patient Examination Gloves-Powder Free | Evergreen Medical Produts (Jingxing) Co., Ltd. | LYZ | Class I | |
| K993921 | Ndd Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001 | NDD Medical Technologies, Inc. | BZG | Class II | |
| K990614 | Hme-Booster | King Systems Corporation. | BTT | Class II | |
| K001358 | Ebi Xfix Dfs Metaphyseal Correction System | Ebi, LLC | KTT | Class II | |
| K001327 | Powdered Latex Exam Gloves, Protein Labeling (150 Microgram or Less) | Premier Pathway Sdn. Bhd. | LYY | Class I | |
| K001319 | Xia Spine System Hooks | Howmedica Osteonics Corp | MNH | Class II | |
| K001307 | Continuum Knee System-Ps Femoral Components- Porous, Model Xx-Yyy-Zzzzz | Implex Corp. | JWH | Class II | |
| K001190 | Polymer Coated, Powder-Free Latex Examination Glove Contains 50 Micrograms or Less of Total Water Extractable Protein Pe | Kossan Latex Industries (M) Sdn Bhd | LYY | Class I | |
| K001155 | Disposable Powdered Nitrile Exam Glove, White Color | Sheen More Ent. Co., Ltd. | LZA | Class I | |
| K001128 | Nitrile Exam Gloves, Powder-Free, Color Blue | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | |
| K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh | Ethicon, Inc | FTL | Class II | |
| K001065 | Disposable Powdered Nitrile Exam Glove, Blue Color | Sheen More Ent. Co., Ltd. | LZA | Class I | |
| K001049 | Guthrie Powder-Free Latex Surgical Glove with (50 Micrograms or Less) | Guthrie Medicare Products (Melaka) Sdn Bhd | KGO | Class I | |
| K001042 | Comfort Latex Powdered Patient Examination Gloves with Protein Label Claim Contains 200 Micrograms or Less of Total Wate | Comfort Rubber Gloves Industries Sdn Bhd | LYY | Class I | |
| K001041 | Agc-Gold Electrolyte for Agc-Micro, Agc-Gold Electrolyte for Agc-Speed, Agc-Goldbonder, Agc Glavanogold | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K001035 | Sensititre 18-24 Hours Susceptibility Plates (Gatifloxacin) | Trek Diagnostic Systems, Ltd. | JWY | Class II |