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 |
|---|---|---|---|---|---|
| K200431 | 3D GraftRasp System | Surgentec LLC | FMF | Class II | |
| K200390 | V.A.C. DERMATAC Drape | KCI USA, Inc. | OMP | Class II | |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | OOE | Class II | |
| K193553 | VarseoSmile Temp | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBG | Class II | |
| K193404 | UF(II) Bar holder abutment | Dio Corporation | NHA | Class II | |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF | Mirus, LLC | MAX | Class II | |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | QEP | Class II | |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Co., Inc. | LPN | Class II | |
| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co.,Ltd. | ONF | Class II | |
| K200479 | AquaPulse Auxiliary Water Connector | GA Health Company Limited | OCX | Class II | |
| K200287 | BP-BT Kiosk | LD Technology LLC | DXN | Class II | |
| K193334 | Pristina Serena Bright | GE Healthcare | MUE | Class II | |
| K193122 | Biocore9 Humeral Resurfacing System | BIOCORE9 LLC | HSD | Class II | |
| K193058 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | OQU | Class II | |
| K191745 | Medtronic Commander Flex | Medtronic Care Management Services | DXN | Class II | |
| K201053 | PercuNav Image Fusion and Interventional Navigation | Philips North America LLC | JAK | Class II | |
| K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics, Inc. | NIG | Class II | |
| K200989 | Reliance Endoscope Processing System | STERIS Corporation | NZA | Class II | |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | Creagh Medical Ltd. | LIT | Class II | |
| K200367 | Distal Humerus Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K200317 | Support Catheter | Qxmedical, LLC | DQY | Class II | |
| K200169 | VFS1 Bipolar Electrosurgical Generator | FHC, Inc. | GEI | Class II | |
| K193436 | VITA Ambria | Vita Zahnfabrik GmbH H Rauter & Co | EIH | Class II | |
| K193293 | XV Lung Ventilation Analysis Software | 4Dx Limited | JAK | Class II | |
| K193096 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K192694 | PAL Single-Use Cannulas | MicroAire Surgical Instruments, LLC | QPB | Class II | |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K192048 | Single Use Endoscope Valves Set | Anrei Medical (HangZhou) CO., Ltd. | ODC | Class II | |
| K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | LPH | Class II | |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | |
| K200991 | EVOL Spinal Interbody System | Cutting Edge Spine | MAX | Class II | |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | Howmedica Osteonics Corp | MBH | Class II | |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | Stryker Sustainability Solutions | NLH | Class II | |
| K200124 | InCore MPJ System | Medartis AG | HWC | Class II | |
| K193055 | Purzir Dental Zirconia | 3DBiocad | EIH | Class II | |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | FTC | Class II | |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | Guangzhou Xinbo Electronic Co., Ltd | GXY | Class II | |
| K201136 | Cure™ Lumbar Plate System | Meditech Spine, LLC | KWQ | Class II | |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K200026 | Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | DSA | Class II | |
| K193457 | AUDERE Lumbar Spacer System | Met One Technologies, LLC | MAX | Class II | |
| K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | NKB | Class II | |
| K192901 | HealthVCF | Zebra Medical Vision, Ltd. | QFM | Class II | |
| K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | FMI | Class II | |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K200501 | ArtiSential Laparoscopic Instrument-Electrodes | LivsMed Inc. | GEI | Class II | |
| K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | MQV | Class II |