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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151802 | Resolution Clip | Boston Scientific Corporation | PKL | Class II | |
| K151623 | Penumbra System 110 Aspiration Tubing | Penumbra Inc. | NRY | Class II | |
| K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System | Nu Vasive, Incorporated | MAX | Class II | |
| K151235 | Medline Foot Plates and Screws | MEDLINE INDUSTRIES, LP - Northfield | HRS | Class II | |
| K151232 | VIKINI Diode Laser System | Ilooda Co,., Ltd. | GEX | Class II | |
| K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K151061 | Cornea Cold | Eurobio | LYX | Unclassified | |
| K151000 | O-Arm O2 Imaging System | Medtronic, Inc. | OWB | Class II | |
| K150819 | Triglycerides | Randox Laboratories, Limited | CDT | Class I | |
| K150614 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | HGM | Class II | |
| K150095 | ReDs Wearable System | Sensible Medical Innovations Inc. | DSB | Class II | |
| K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | OLO | Class II | |
| K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | LTK | Class II | |
| K142689 | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | Apex Biotechnology Corp. | CGA | Class II | |
| K151818 | SImmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | OUR | Class II | |
| K151286 | OPTIS Integrated System Mobile Workstation | Lightlab Imaging, Inc. | NQQ | Class II | |
| K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges | Straumann USA, LLC | NHA | Class II | |
| K151023 | Compact Piezo LED | Mectron S.p.A. | ELC | Class II | |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | |
| K150086 | Titan | Tzora Active Systems, Ltd. | INI | Class II | |
| K143700 | CPAP Cannulaide | Salter Labs | BZD | Class II | |
| K132929 | Sd Gluconavii Mentor Nfc Multi Blood Glucose Monitoring System, and Sd Gluconavii Mentor Nfc Blood Glucose Monitoring System | SD Biosensor, Inc. | NBW | Class II | |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | IWB | Class II | |
| K151325 | Bovie J-Plasma Handpiece | Apyx Medical Corporation | GEI | Class II | |
| K151219 | Models 2200DR and 1600DR Digital Stationary Radiographic Systems | Beijing Polycon Medical Engineering Company | KPR | Class II | |
| K150973 | NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs | Terang Nusa Snd Bhd | KGO | Class I | |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | MQB | Class II | |
| K150871 | ForeFoot STP System | TORNIER Inc. | HWC | Class II | |
| K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot | Medtronic, Inc. | GEI | Class II | |
| K143554 | Venus Legacy CX | Venus Concept Inc. | PBX | Class II | |
| K143292 | TheraCal DC | Bisco Inc | EJK | Class II | |
| K151687 | QuantorView | 3Disc Americas | LLZ | Class II | |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | KANEKA Corporation | DQY | Class II | |
| K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | DQX | Class II | |
| K142943 | Metallic Locking Bone Plate and Screw | Canwell Medical Co., Ltd. | HRS | Class II | |
| K140432 | Hi-Light, Hi-Light Plus | Dentall, Inc. | EBZ | Class II | |
| K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | LHI | Class II | |
| K151904 | SyncVision System | Volcano Corporation | OWB | Class II | |
| K151813 | Sniper Spine System | Spine Wave Inc | MNI | Class II | |
| K151568 | Arthrex OrthoVis Preoperative Plan | Custom Orthopaedic Solutions, Inc. | LLZ | Class II | |
| K151483 | Biomet Spine Fusion System | Highridge Medical, LLC | MAX | Class II | |
| K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | DXC | Class II | |
| K151204 | HEMO-Bandage | Coreleader Biotech Co., Ltd | QSY | Unclassified | |
| K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner | Sopro - Acteon Group | MUH | Class II | |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk a/S | FMF | Class II | |
| K150752 | GME ExSys 308 | Gme German Medical Engineering GmbH | FTC | Class II | |
| K150641 | MagVita TMS Therapy System | Tonica Elektronik a/S | OBP | Class II | |
| K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe GmbH | NBW | Class II | |
| K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | HIF | Class II |