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 |
|---|---|---|---|---|---|
| K971187 | Standard & Extended Blade/needle/ball;modified Standard & Extended Blade/needle | Apyx Medical Corporation | JOS | Class II | |
| K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | GEI | Class II | |
| K970902 | Medilog Fd4 | Oxford Instruments Medical Systems | DSH | Class II | |
| K970892 | Fiegert Endotech Cystoscope | Fiegert, Inc. | FAJ | Class II | |
| K970863 | Modified Ussc* Polysorb Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K970750 | Microspan Insemination System | Imagyn Medical, Inc. | MFD | Class II | |
| K970673 | Disposable Vitrectomy Probe | Altex Vision | HQE | Class II | |
| K970530 | Anspach Lubricating System II | The Anspach Effort, Inc. | GEY | Class I | |
| K970431 | Behring Coagulation System | Behring Diagnostics, Inc. | JPA | Class II | |
| K965092 | Vidas Rotavirus Assay | Biomerieux Vitek, Inc. | LIQ | Class I | |
| K965045 | Tristar Lp Torcar with Low Profile Threaded Sleeve | Ethicon Endo-Surgery Inc | HET | Class II | |
| K964972 | Shadowform | Izi Medical Products LLC | KPQ | Class II | |
| K964625 | Hemapatch Vascular Patches, Intergard and Intergard-Rs Vascular Prostheses | Intervascular, Inc. | DSY | Class II | |
| K964178 | Press-Fit Hip Stem | Encore Orthopedics, Inc. | LWJ | Class II | |
| K963166 | O'regan Ligator | Patrick J. O'Regan | FHN | Class II | |
| K963054 | Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130) | Genbio | LJZ | Class I | |
| K960068 | Sh-1 Surgical Holder for Telescope | OLYMPUS Corporation of the Americas | OCV | Class II | |
| K933841 | Centauri | Premier Laser Systems, Inc. | GEX | Class II | |
| K932683 | Centauri | Premier Laser Systems, Inc. | GEX | Class II | |
| K971445 | Alb or Albumin | Carolina Liquid Chemistries | CIX | Class II | |
| K971398 | Ld-L Reagent | Carolina Liquid Chemistries | CFJ | Class II | |
| K971221 | Greiner Vacuette Blood Collection Tube | Greiner America, Inc. | GIM | Class II | |
| K971045 | Basis Flexible Tip Digital Thermometer | Polymedica Industries, Inc. | FLL | Class II | |
| K970974 | Williams Sound, Personal Fm System, Hearing Helper | Williams Sound, LLC | LZI | Class II | |
| K970952 | Precise Impression Kit | Starkey Laboratories, Inc. | ESD | Class I | |
| K970910 | Xomed Silicone Block/strip | Xomed, Inc. | KHJ | Class II | |
| K970870 | Digit-Grip with Lcd (Dgr002) | Nk Biotechnical Corp. | HRW | Class I | |
| K970806 | Acpii Anterior Cervical Plate System | Sofamor Danek USA,Inc. | KWQ | Class II | |
| K970687 | Williams Sound, Personal Fm, Hearing Helper | Williams Sound, LLC | EPF | Class II | |
| K970676 | Dried Gram-Negative Mic/combo Panels | Dade Intl., Inc. | JWY | Class II | |
| K970665 | Williams Sound, Personal Fm, Hearing Helper | Williams Sound, LLC | EPF | Class II | |
| K970652 | Mitra Imaging, Inc. Film Express Scanning Software | Mitra Imaging, Inc. | LMD | Class I | |
| K970641 | Ris Scanview System (Rsvs) | Radiology Information Systems, Inc. | LMD | Class I | |
| K970490 | Proform General Application Cemented Femoral Component | Globus Medical, Inc. | LZO | Class II | |
| K970400 | Bone Source Hydroxyapatite | Orthofix SRL | LZK | Class II | |
| K970234 | Sealed Lead Acid Battery Pack | Portable Power Systems, Inc. | IZL | Class II | |
| K964797 | Ebi Spinelink System | Electro-Biology, Inc. | KWQ | Class II | |
| K963782 | Bard Memotherm Transhepatic Biliary Endoprosthesis | C.R. Bard Inc | FGE | Class II | |
| K963418 | Transmedica Model 100 Digital Electronic Stethoscope | Transmedica, Inc. | DQD | Class II | |
| K963055 | Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120 | Genbio | LJZ | Class I | |
| K962807 | American Surgical Sponges/neurosurgical Sponges | American Surgical Sponges | HBA | Class II | |
| K971266 | Safe-Connect Y-Site Adapter Catalog No. 681518 | Faulding Medical Device Co. | FPA | Class II | |
| K970789 | Safe-Connect Vial Dispensing Spike | Faulding Medical Device Co. | LHI | Class II | |
| K970473 | Etest Submission for Azithromycin/s. Pneumoniae | Ab Biodisk | JWY | Class II | |
| K970379 | Channel Balloon Catheter | Boston Scientific Corporation | LIT | Class II | |
| K970210 | Amikacin | Ab Biodisk | JWY | Class II | |
| K970174 | Freepix/pixpacs Dicom/http Gateway | Pixelinks, Inc. | LMD | Class I | |
| K964236 | (Modified) Etest Package Insert | Ab Biodisk | JWY | Class II | |
| K964187 | Fukada Denshi Dynascope Model Ds-5300 Patient Monitor | Fukuda Denshi USA, Inc. | DSI | Class II | |
| K963289 | Incstar Toxoplasma Igm Capture Elisa Assay | Incstar Corp. | LGD | Class II |