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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K191569 | Implantcast ic-Bipolar Head System | implantcast GmbH | KWY | Class II | |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K191424 | Interphalangeal Joint Fusion Device Range | Neosteo | HWC | Class II | |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | JDI | Class II | |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | LZO | Class II | |
| K190904 | Conformis BeneFIT Hip System | ConforMIS, Inc. | LPH | Class II | |
| K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K190437 | Delta 3300 | Netech Corp. | DRL | Class II | |
| K190269 | PureLift | Xtreem Pulse | NFO | Class II | |
| K183485 | CryoVizion System | Cryos Technologies, Inc. | LDK | Unclassified | |
| K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter | Amzetta Technologies Private Limited | MWI | Class II | |
| K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | HEB | Class II | |
| K191107 | Plexus | Alleva Medical (D.G.) Ltd | JOW | Class II | |
| K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | Medtronic, Inc. | KFM | Class II | |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | |
| K191427 | Halley resin system | Dentsply Sirona Inc | EBI | Class II | |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, Inc. | NHA | Class II | |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K183122 | 810nm Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | GEX | Class II | |
| K192047 | Rampart™ One Lumbar Interbody Fusion System | Spineology, Inc. | OVD | Class II | |
| K191990 | OSW Aligner System | Osw Manufacturing, LLC | NXC | Class II | |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | KWL | Class II | |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker Corp. | HRS | Class II | |
| K191180 | Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head | Smith & Nephew, Inc. | GCJ | Class II | |
| K191130 | Customized Contour Implant | Implantech Associates Inc | FWP | Class II | |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | QEY | Class II | |
| K191063 | 1-Step Culture Medium | Shenzhen VitaVitro Biotech Co.,Ltd. | MQL | Class II | |
| K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | PON | Class II | |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | DQK | Class II | |
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | FJI | Class II | |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC. | NLH | Class II | |
| K183684 | Libertas – Taper Uncemented Femoral Stem | Maxx Orthopedics Inc. | LZO | Class II | |
| K183607 | FUJIFILM Bronchoscope | FUJIFILM Corporation | EOQ | Class II | |
| K183567 | Vyntus/SentrySuite Product Line | Jaeger Medical GmbH | BZC | Class II | |
| K183544 | Efficient Care 3D Planning | Orthosoft Inc (D/B/A Zimmer Cas) | LLZ | Class II | |
| K183315 | CustMBite Dental Guard | Dental Choice Holdings LLC | OBR | Unclassified | |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | JCX | Class II | |
| K192021 | NCB Polyaxial Locking Plate System | Zimmer GmbH | HRS | Class II | |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | bioMerieux, Inc. | JWY | Class II | |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL | MAI | Class II | |
| K190792 | Bb-613Wp | Biobeat Technologies Ltd | DQA | Class II | |
| K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | JWH | Class II | |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies Ltd. | DQO | Class II | |
| K181888 | Osstell Beacon | Osstell AB | EKX | Class I | |
| K191948 | GlideScope BFlex 5.8 Single-Use Bronchoscope | Verathon Medical (Canada) ULC | EOQ | Class II | |
| K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | MUH | Class II | |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | PZX | Class II |