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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K233342 | Cina-Aspects | Avicenna.ai | POK | Class II | |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | ONF | Class II | |
| K232327 | Endorail | Endostart SRL | ODC | Class II | |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | FOZ | Class II | |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co., Ltd. | QNQ | Class II | |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | GJS | Class II | |
| K233958 | hekaDrill | Zethon Ltd | ERL | Class II | |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | MQK | Class II | |
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | NxStage Medical Inc | KDI | Class II | |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. | NAY | Class II | |
| K232567 | Myriad SPECTRA Light Source | Nico Corporation | QFX | Class II | |
| K232301 | Define RF Microneedling System | Aesthetic Management Partners | GEI | Class II | |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | NKG | Class II | |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | PNP | Class II | |
| K234055 | DEKA Loop | Deka Research & Development Corp. | QJI | Class II | |
| K234008 | Cerament G | Bonesupport Inc | QRR | Class II | |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific Corporation | GEH | Class II | |
| K233968 | CINA-iPE | Avicenna.ai | QAS | Class II | |
| K233952 | DEKA ACE Pump System | Deka Research & Development Corp. | QFG | Class II | |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | JDQ | Class II | |
| K233946 | Immulite® 2000 Br-Ma | Siemens Healthcare Diagnostics Products Limited | MOI | Class II | |
| K233930 | MRCP+ version 2 (MRCP+ v2) | Perspectum Ltd. | LLZ | Class II | |
| K233592 | BioPoly Radial Head Implant | Biopoly, LLC | KWI | Class II | |
| K233466 | Edison System | Histosonics, Inc | QGM | Class II | |
| K233136 | Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | |
| K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | Chongqing Rob Linka Science and Technology Co., Ltd. | NGX | Class II | |
| K232022 | CAS-One IR | Cascination | JAK | Class II | |
| K240497 | Smartxide Tetra Pro | El.En S.p.A. | GEX | Class II | |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Collagen Matrix, Inc | MQV | Class II | |
| K240416 | Tranquil-C Interbody System | Nexus Spine, L.L.C. | ODP | Class II | |
| K240132 | EmoLED (v. 2-USA) | Emoled SRL | GEX | Class II | |
| K233381 | DRX-Evolution Plus System | Eastman Kodak Company | KPR | Class II | |
| K232564 | Align Studio | Laon Medi Inc. | PNN | Class II | |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare Corporation | KDJ | Class II | |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited | LFD | Unclassified | |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K233922 | Sp Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; Nwt Can Slim LED Cord G3 Short; Nwt Can Slim LED Cord G3 Long | Satelec-Acteon Group | ELC | Class II | |
| K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | HWC | Class II | |
| K233724 | 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LZO | Class II | |
| K232140 | OTS Hip | Ortoma AB | OLO | Class II | |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co.,Ltd. | EBW | Class I | |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd | NGX | Class II | |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics Inc | QOF | Class II | |
| K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA | Class II | |
| K240396 | Elite iQ PRO (M122K1) | Cynosure, LLC | GEX | Class II | |
| K240384 | SENDERO Microcatheter | Okami Medical Inc. | DQY | Class II | |
| K240264 | Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | Class II | |
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II |