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 |
|---|---|---|---|---|---|
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | Ortho-Clinical Diagnostics, Inc. | PSZ | Class II | |
| K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Laboratories | HQC | Class II | |
| K161743 | Etgar Dental Implant System | Etgar Medical Instruments, Ltd. | DZE | Class II | |
| K161741 | Gmk Uni | Medacta International SA | HSX | Class II | |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, Inc. | PKR | Class II | |
| K170610 | PlasmaBlade T | Medtronic Navigation, Inc | GEI | Class II | |
| K170502 | Patient Positioning System | Forte Automation Systems, Inc. | JAI | Class II | |
| K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | HRS | Class II | |
| K170055 | CAPRI Corpectomy Cage System | K2M, Inc | MQP | Class II | |
| K163461 | Coolief* Cooled RF Probe | Halyard Health | GXI | Class II | |
| K163443 | Interson USB Ultrasound System | Interson Corp. | IYN | Class II | |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | Titan Spine, LLC | OVD | Class II | |
| K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner | PENTAX of America, Inc. | ODG | Class II | |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | HWC | Class II | |
| K161179 | Intelli-Ox | Air Liquide Healthcare America | ECX | Class I | |
| K170386 | BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle | Becton Dickinson & Co | FMF | Class II | |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | AD-Tech Medical Instrument Corp. | GZL | Class II | |
| K161114 | High V+ | Teknimed SAS | NDN | Class II | |
| DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | |
| K170788 | CyberKnife Treatment Delivery System | Accuray Incorportaed | IYE | Class II | |
| K170580 | Carestream Vue PACS | Eastman Kodak Company | LLZ | Class II | |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb Incorporated | LPN | Class II | |
| K170445 | Logiq S8 | GE Healthcare | IYN | Class II | |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | C.R. Bard Inc | GDW | Class II | |
| K163617 | REMbrandt | Embla Systems | OLZ | Class II | |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Neurovirtual USA, Inc. | GXY | Class II | |
| K163021 | Haag-Streit Fundus Module 300 | Optomed | HKI | Class II | |
| K162046 | MINNE TIES MMF Suture System | Summit Medical, LLC | DYX | Class II | |
| K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | PTC | Class I | |
| K163386 | Keos Lumbar IBFD | Keos | MAX | Class II | |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Medical | CGA | Class II | |
| K163192 | Comfort EC710 | Alltech Medical Systems America, Inc. | LNH | Class II | |
| K163125 | geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators | Firstkind Ltd | IPF | Class II | |
| K162968 | Vortran Go2vent | Vortran Medical Technology 1, Inc | BTL | Class II | |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | PSZ | Class II | |
| K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | MBF | Class II | |
| K170813 | Orthopantomograph Op 3D | Palodex Group Oy | OAS | Class II | |
| K170724 | NeuroBlate System | Monteris Medical Corp | GEX | Class II | |
| K170598 | ZeroWire Mobile | NDS Surgical Imaging, LLC | GCJ | Class II | |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics Corp. | MCW | Class II | |
| K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | LOX | Class II | |
| K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | HRS | Class II | |
| K163265 | Kepler II | Orbbo Surgical, LLC | ODP | Class II | |
| K163144 | gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) | Gke-GmbH | FRC | Class II | |
| K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | CBK | Class II | |
| K162838 | Philips iCT CT System | Philips North America LLC | JAK | Class II | |
| K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | BTR | Class II | |
| K160549 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | GEX | Class II | |
| K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II |