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 |
|---|---|---|---|---|---|
| K964623 | Titanium Cd Horizon Anterior Spinal System | Sofamor Danek USA,Inc. | KWQ | Class II | |
| K964614 | Ultrafera Wound Dressing | American White Cross, Inc. | KMF | Class I | |
| K964521 | Depuy Dupont Phantom Suture Anchor | Depuy, Inc. | MAI | Class II | |
| K964512 | Ceftizoxime Antimicrobial Susceptibility Test Disc | Unipath, Ltd. | JTN | Class II | |
| K964501 | Sulbactam/ampicillin Antimicrobial Susceptibility Test Disc | Unipath, Ltd. | JTN | Class II | |
| K964497 | Ceralas Diode Laser System (Ceralas D15) | Ceram Optec, Inc. | GEX | Class II | |
| K964496 | Cefixime Antimicrobial Susceptibilty Test Disc | Unipath, Ltd. | JTN | Class II | |
| K964493 | Ofloxacin Antimicrobial Susceptibility Test Disc | Unipath, Ltd. | JTN | Class II | |
| K964401 | Kendall-Ltp Disposable Temperature Probes (Dtp1,dtp2,dtp3,dtp4) | Ludlow Technical Products | FMT | Class II | |
| K964139 | Sysmex Ca-6000 | Dade Intl., Inc. | GKP | Class II | |
| K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | HRS | Class II | |
| K963680 | Target Myoglobin Test | Texas Immunology, Inc. | DDR | Class II | |
| K963302 | Tayman Medical, Inc. Stepping & Stabilizing System | Tayman Medical, Inc. | ITX | Class II | |
| K963139 | Olympus Transferrin Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | DDD | Class II | |
| K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | GZJ | Class II | |
| K962708 | Titanium Cd Horizon Spinal System | Sofamor Danek USA,Inc. | KWP | Class II | |
| K962603 | Masimo Set Ms-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corporation | DQA | Class II | |
| K962335 | Mlc Fit | Elekta Limited | IYE | Class II | |
| K961498 | Resch Arthroscopic and Percutaneous Screw Fixation System (A.s.f.) | Howmedica Corp. | HRS | Class II | |
| K960659 | Ceramic Spherical Cmc Implant (Subject to Marketing Approval) | Wrightmedicaltechnologyinc | KYI | Class II | |
| K960534 | Metallic Spherical Cmc Implant | Wrightmedicaltechnologyinc | KYI | Class II | |
| K954003 | Cobe Hemodynamic Recirculation Monitor | Cobe Renal Care, Inc. | MQS | Class II | |
| K953175 | As/3 Estpr Module | Datex Division Instrumentarium Corp. | MLD | Class II | |
| K965006 | At 62 EEG (A.k.a the A;pha-Theta Trainer) | Stoelting Co. | HCC | Class II | |
| K964735 | Dentinsense | Centrix, Inc. | KLE | Class II | |
| K962105 | Planned Sophied Classic | Planmed Oy | IZH | Class II | |
| K960037 | Sugita Avm Microclip | Mizuho America, Inc. | HCH | Class II | |
| K965227 | Osom Classic Hcg-Urine Test (115) | Wyntek Diagnostics, Inc. | JHI | Class II | |
| K965184 | Perfecta Pregnancy Test | Wyntek Diagnostics, Inc. | LCX | Class II | |
| K965168 | Stablelin Enzyme Linearity Test Set B (Item No. 002) | Specialized Assays, Inc. | JJT | Class I | |
| K965166 | Stablelin Enzyme Linerarity Test Set a (Item No. 001) | Specialized Assays, Inc. | JJT | Class I | |
| K965159 | Cetibuten, 30Mcg, Sensi-Disc | Becton Dickinson Microbiology Systems | JTN | Class II | |
| K965047 | Mink Lung Cell Culture | Neogenex | KIR | Class I | |
| K964914 | Alkaline Phosphatase | Derma Media Lab., Inc. | CJE | Class II | |
| K964892 | Femrx Turp Sr System (Ts27xx-Yy/ts24xx-Yy) | Gynecare Innovation Center | FJL | Class II | |
| K964864 | Prospect II Clostridium Diffillie Toxin a Microplate Assay | Alexon Biomedical, Inc. | LLH | Class I | |
| K964771 | De-Tox Control 1 and De-Tox Control 19 | Dyna-Tek Industries | DIF | Class I | |
| K964720 | Vitros Immunodiagnostics Products Fsh Reagent Pack (Gem. 1005) Fsh Calibrators (Gem.c005) | Johnson & Johnson Clinical Diagnostics, Inc. | CGJ | Class I | |
| K964691 | Tcb Temporary Crown and Bridge Material | Scican Ltd. | EBG | Class II | |
| K964670 | Roche Cobas-Fp Reagents for Tobramycin | Roche Diagnostic Systems, Inc. | LFW | Class II | |
| K964608 | Mrt-35A V9.0 | Toshiba America Mri, Inc. | LNH | Class II | |
| K964575 | Sympacath Hydrogel Coated Foley | Rusch Intl. | EZL | Class II | |
| K964494 | Sleepwizard | Medtronic, Inc. | MNR | Class II | |
| K964485 | Portpro Electronic Portal Imaging System | Eliav, Ltd. | IYE | Class II | |
| K964419 | Miracle - Ear (Ite/itc/cic) | Miracle-Ear, Inc. | ESD | Class I | |
| K964245 | Precise, Tynmpanette, and Xacto Impression Kits | Starkey Laboratories, Inc. | ESD | Class I | |
| K963673 | Immage Immunochemistry System Tdm (Car,phe,phy, & the) Reagents | Beckman Instruments, Inc. | KLT | Class II | |
| K963645 | Herpes Group Igg Elisa Test System | Armkel, LLC | LGC | Class II | |
| K963104 | 9.5 Fr.- Flexi-Cath Intra-Aortic and Control System | Arrow Intl., Inc. | DSP | Class II | |
| K962653 | Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit | Microgyn Corp. | FAS | Class II |