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 |
|---|---|---|---|---|---|
| K241402 | Medical Monitor (32HR734S) | LG Electronics.Inc | GCJ | Class II | |
| K241365 | Pixie Pulse (SM9068) | Pixie Cup LLC | NUH | Class II | |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. | MAX | Class II | |
| K240868 | Ultravision2™ IonPencil | Alesi Surgical Ltd | PQM | Class II | |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | ID-Fish Technology, Inc | LSR | Class II | |
| DEN210037 | SoClean 3+ Bacterial Reduction Device | SoClean, Inc. | QXQ | Class II | |
| K242016 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K241376 | HyperSuture All Blue Extension Line | Threadstone LLC | GAT | Class II | |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | Surgentec LLC | KNW | Class II | |
| K240469 | Access TPO Antibody | Siemens Healthcare Diagnostics Inc. | JZO | Class II | |
| K240079 | Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) | Suzhou Ideal Medical Co., Ltd. | ITI | Class II | |
| K234053 | F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Inc. | CBP | Class II | |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Inc. | MNT | Class II | |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas SA | CHH | Class I | |
| K231950 | Medidiode | Medicreations LLC | GEX | Class II | |
| K222688 | The Trust | GENOSS Co., Ltd. | EKX | Class I | |
| K242009 | 360CAS Knee | Kico Knee Innovation Company | OLO | Class II | |
| K241665 | Omni Legend | GE Medical Systems Israel, Functional Imaging | KPS | Class II | |
| K240724 | SynthVISION 1.0.0 | Synthesis Health Intelligence Inc. | LLZ | Class II | |
| K240229 | Masimo W1 | Masimo Corporation | DPS | Class II | |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K233844 | OdneClean | Odne AG | ELC | Class II | |
| K233822 | i2Contour | Mrimath, LLC | QIH | Class II | |
| K233720 | Luminopia | Luminopia Inc | QQU | Class II | |
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | DWE | Class II | |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | NXC | Class II | |
| K233315 | HipXpert and HipInsight System | Surgical Planning Associates | OSF | Class II | |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | AKTORmed GmbH | QZB | Class II | |
| K231775 | GR Resin System MSI | PRO3DURE Medical GmbH | MQC | Unclassified | |
| K241685 | SofWave System | Sofwave Medical Ltd. | NGX | Class II | |
| K241644 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | |
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | |
| K240605 | Ultra RapidWarm™ Blast | Vitrolife Sweden AB | MQL | Class II | |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | FRG | Class II | |
| K240255 | Electric Wheelchair (JLE-W01A-2023) | Zhejiang Jianrui Technology Co., Ltd | ITI | Class II | |
| K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | LSE | Class I | |
| K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | LLM | Class I | |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic, Inc. | MTD | Class II | |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | QPB | Class II | |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | DYB | Class II | |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | QTZ | Class II | |
| K233920 | EOSedge | EOS imaging | KPR | Class II | |
| K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical, Inc. | GEI | Class II | |
| K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | |
| K240953 | AI Platform 2.0 (AIP002) | Exo Imaging, Inc. | QIH | Class II | |
| K240932 | HybridTherm System | ERBE Elektromedizin GmbH | GEI | Class II | |
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | Pulse Biosciences, Inc. | GEI | Class II | |
| K240127 | PlumeSafe X5 Smoke Management System | ConMed Corporation | FYD | Class II |