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 |
|---|---|---|---|---|---|
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing Huacheng Taike Technology Co., Ltd. | GEX | Class II | |
| K253797 | One-Stop | Mediclus Co., Ltd | MVL | Unclassified | |
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care, LLC | LFD | Unclassified | |
| K253695 | LigaMend | Riverpoint Medical, LLC | MBI | Class II | |
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies Inc. | ETN | Class II | |
| K253535 | Ligence Heart | Ligence UAB | QIH | Class II | |
| K252714 | C-Lant Port | Vigor Medical Technologies, Ltd. | GCJ | Class II | |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | DQA | Class II | |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K260254 | Enbio PRO | Enbio Group AG | FLE | Class II | |
| K254271 | Capri | ORO Co., Ltd. | GEX | Class II | |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd | HIH | Class II | |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & Co. KG | OWN | Class II | |
| K254182 | Aster | Osteonic Co., Ltd. | KWQ | Class II | |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | MAX | Class II | |
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | KCT | Class II | |
| K253764 | ENOS Software Guided External Fixation System | Disior Oy | OSN | Class II | |
| K253641 | Owl Night Guard | Owl Dental Lab, Inc. | OBR | Unclassified | |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical Ltd. | QAS | Class II | |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International SA | MBH | Class II | |
| K253021 | ANNE Maternal | Sibel Health Inc. | HGM | Class II | |
| K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | HRS | Class II | |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | FYA | Class II | |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | Speciality Fibres and Materials Limited | QSY | Unclassified | |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | |
| K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson & Company (BD) | FQH | Class II | |
| K253789 | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | ITI | Class II | |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc | OVD | Class II | |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | PQC | Class II | |
| K251724 | Remi Impression Material | Grindguard Inc | SHI | Class II | |
| K251687 | Konig Bell Circumcision Clamp | MEDLINE INDUSTRIES, LP - Northfield | HFX | Class II | |
| K260377 | XSense Cryoablation System with CryoProbes | Icecure Medical Ltd | GEH | Class II | |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | GEI | Class II | |
| K260217 | AI Platform 2.2 (AIP002) | Exo Imaging, Inc. | QIH | Class II | |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek | JOW | Class II | |
| K254247 | Osteomni Spinal Fixation System | Osteomni Inc | NKB | Class II | |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | MAI | Class II | |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | IYO | Class II | |
| K253707 | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | ITI | Class II | |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences LLC | DQK | Class II | |
| K252599 | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics Ltd. | GEX | Class II | |
| K251678 | Swift Ray 1 | Swift Medical | QJF | Class II | |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance Ltd. | LNH | Class II | |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | DWF | Class II | |
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | Class II | |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | INI | Class II | |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | MAX | Class II | |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corp | KGW | Class II |