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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180185 | Bio-C Repair | Angelus Industria de Produtos Odontologicos S/A | KIF | Class II | |
| K180006 | AmCAD-UT Detection 2.2 | Amcad Biomed Corporation | LLZ | Class II | |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Abbott Medical | ONB | Class II | |
| K173368 | Reusable & Disposable SpO2 Sensors | Shenzhen Coreray Technology Co., Ltd. | DQA | Class II | |
| K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | CAF | Class II | |
| K182024 | Dissecting Balloon System | Applied Medical Resources Corp | GCJ | Class II | |
| K181997 | Swiss LithoClast Trilogy | E.M.S. - Electro Medical Systems SA | FEO | Class II | |
| K181513 | Arthrex PushLock Tenodesis Anchor | Arthrex GmbH | MBI | Class II | |
| K181486 | DEKA Motus AY | El.en. Electronic Engineering SpA | GEX | Class II | |
| K181262 | SpineJack Expansion Kit | Vexim SA | NDN | Class II | |
| K180888 | Lyft | Uplevity, Inc. | OLP | Class II | |
| K180536 | Neodent Implant System – GM Line | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K173648 | Spectralis HRA + OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | |
| K173623 | Anchor plate | Biomaterials Korea Inc. | OAT | Class II | |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Ortho-Clinical Diagnostics, Inc. | LSR | Class II | |
| K173380 | b-ONE® Total Hip System | b-ONE Ortho Corp. | LZO | Class II | |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | HGM | Class II | |
| K182119 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K182054 | Natrelle 133S Tissue Expander | Allergan | LCJ | Unclassified | |
| K181799 | ResCUBE™ Ligament Fixation System | Cousin Biotech SAS | OWI | Class II | |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics Inc | OOK | Class II | |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | DQK | Class II | |
| K181471 | ACCUFUSE Cervical System | Absolute Advantage Medical, LLC | ODP | Class II | |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine | OVE | Class II | |
| K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | LLZ | Class II | |
| K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co.,Ltd. | DXN | Class II | |
| K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | KLE | Class II | |
| K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | GZT | Class II | |
| K180496 | TruClear Elite Hysteroscope | Medtronic, Inc. | HIH | Class II | |
| K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | Shenzhen Vitavitro Bio-Tech Co., Ltd. | MQL | Class II | |
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | BZR | Class II | |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | KWL | Class II | |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | Microbiologics, Inc. | PMN | Class II | |
| K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health | LFL | Unclassified | |
| K181069 | Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | Class II | |
| K173952 | Universal SmartECG | VectraCor, Inc. | DPS | Class II | |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corp. | NEW | Class II | |
| K181483 | Tranquil Interbody System | Nexus Spine, L.L.C. | MAX | Class II | |
| K181473 | DENV Detect NS1 ELISA | Inbios International, Inc. | QCU | Class II | |
| K181408 | JO Classic Hybrid Personal Lubricant | United Consortium | NUC | Class II | |
| K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | IYN | Class II | |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II | |
| K181609 | RadiForce GX560, GX560-AR | Eizo Corporation | PGY | Class II | |
| K181386 | NuVasive Brigade Lateral System | Nu Vasive, Incorporated | OVD | Class II | |
| K181060 | Solitaire 2 and Solitaire Platinum Revascularization Device | Medtronic Neurovascular | POL | Class II | |
| K181035 | AOS Small Fragment Plating System Lite | Advanced Orthopaedic Solutions, Inc. (Aos) | HRS | Class II | |
| K181009 | APTUS CMC-I Fusion Plate System | Medartis AG | HRS | Class II | |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical LLC | MAX | Class II | |
| K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw | Orthofix SRL | NKB | Class II | |
| K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter | Abbott Vascular | LOX | Class II |