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 |
|---|---|---|---|---|---|
| K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | JOJ | Class II | |
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (BD Diagnostics) | PQA | Class II | |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | MUD | Class II | |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | KWH | Class II | |
| K190054 | BD Insulin Syringe | Becton Dickinson & Co | FMF | Class II | |
| K182862 | Servo Guard | Maquet Critical Care AB | CAH | Class II | |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K192532 | Arthrex SwiveLock Anchor | Arthrex GmbH | MAI | Class II | |
| K191513 | Altapore Shape | Baxter Healthcare Corporation | MQV | Class II | |
| K190636 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | NKB | Class II | |
| K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | MAX | Class II | |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | QEY | Class II | |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott Medical | MXC | Class II | |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | LGZ | Class II | |
| K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | Medos International SARL | OLO | Class II | |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | PDQ | Class II | |
| K191668 | Infrared Forehead Thermometer (Model IR-FT) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | FLL | Class II | |
| K191544 | Synapse 3D Blood Flow Analysis | FUJIFILM Corporation | LLZ | Class II | |
| K191436 | Saalio | Saalmann Medical GmbH & Co. KG | EGJ | Class II | |
| K191430 | Pulse Oximeter | Shenzhen Yimi Life Technology Co.,Ltd | DQA | Class II | |
| K191283 | Infrared Thermometer, Breeze model | Suzhou Melodicare Medical Technology Co., Ltd | FLL | Class II | |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | KOI | Class II | |
| K190646 | QT Scanner 2000 Model A | Qt Ultrasound, LLC | IYO | Class II | |
| K190465 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | |
| K190342 | BIAFINE Topical Cream | Bausch Health Americas Incorporated | FRO | Unclassified | |
| K183625 | SomnaPatch | Respironics, Inc. | MNR | Class II | |
| K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | |
| K183226 | Care Orchestrator Essence | Respironics, Inc. | BZD | Class II | |
| K181896 | LIPOcel | Jeisys Medical Inc. | OHV | Class II | |
| K192566 | Reach and CQ'ENCE Circular Staplers | Reach Surgical, Inc. | GDW | Class II | |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | DSH | Class II | |
| K192455 | Merge PACS | Merge Healthcare Incorporated | LLZ | Class II | |
| K192441 | Arthrex SwiveLock Anchors | Arthrex GmbH | MAI | Class II | |
| K192316 | Matrix HA PEEK Cervical Implant System | Sapphire Medical Group | ODP | Class II | |
| K192239 | WavelinQ Plus EndoAVF System | C.R. Bard Inc | PQK | Class II | |
| K192175 | On Call Express II Blood Glucose Monitoring System | Acon Laboratories, Inc. | NBW | Class II | |
| K191942 | MT One Diamond | M&T SRL | GEX | Class II | |
| K191653 | Freestyle Flex | Medela AG | HGX | Class II | |
| K191216 | Voxel Dosimetry™ v1.0 | Hermes Medical Solutions AB | LLZ | Class II | |
| K190162 | SmartCeph | ORTHO2 | LLZ | Class II | |
| K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System | Osprey Medical, Inc. | DXT | Class II | |
| K183503 | EasyMark Tissue Marker | Inrad | NEU | Class II | |
| K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento e Inovacao Tecnologica S.A. | GWM | Class II | |
| K192541 | DigiX FDX | Allengers Medical Systems Limited | KPR | Class II | |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K191771 | SECURE Screw | A.M. Surgical, Inc. | HWC | Class II | |
| K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics Ltd. | LLZ | Class II | |
| K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | Arthrex GmbH | HRS | Class II | |
| K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt., Ltd. | KTT | Class II |