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 |
|---|---|---|---|---|---|
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | GWL | Class II | |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical | LZG | Class II | |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | FUJIFILM Corporation | FDS | Class II | |
| K233977 | Velacur | Sonic Incytes | IYO | Class II | |
| K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | OAT | Class II | |
| K231095 | Tamper Evident Cap | Intl. Medical Industries | FMF | Class II | |
| K221275 | Qraycam PRO | Aiobio Co., Ltd. | NBL | Class II | |
| K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | Penumbra Inc. | QEW | Class II | |
| K242251 | Litho 60; Litho 100; Litho 150 | Quanta System Inc. | GEX | Class II | |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | Eminent Spine | NKB | Class II | |
| K241611 | ShapeIT (SI014135) | IMDS Operations B.V. | DQY | Class II | |
| K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K240487 | EVOS Patella Plates | Smith & Nephew, Inc. | HRS | Class II | |
| K233805 | K5 | OSSTEM Implant Co., Ltd. Chair Business | EIA | Class I | |
| K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex GmbH | HWC | Class II | |
| K242300 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corp. | LZO | Class II | |
| K241957 | Talee, Talee PostOp | Invent Medical USA, LLC | MVA | Class II | |
| K241847 | Imbio PHA (4.0.0) | Imbio, Inc. | QIH | Class II | |
| K241823 | ToxiSeal™ Vial Adaptor | Epic Medical Pte., Ltd. | ONB | Class II | |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | ITX | Class II | |
| K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH | Class II | |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Remington Medical | DPW | Class II | |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | Magstim Inc. | OBP | Class II | |
| K241393 | ODI-Tech | Odi Medical AS | MUD | Class II | |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | JAQ | Class II | |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | OYK | Class II | |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | |
| K241256 | JetBoots PRO Plus | Therabody, Inc. | IRP | Class II | |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | OYK | Class II | |
| K241051 | Vave Wireless Ultrasound System | Vave Health Inc | IYN | Class II | |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific Corporation | FGE | Class II | |
| K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | NKB | Class II | |
| K240003 | Velmeni for Dentists (V4D) | Velmeni | MYN | Class II | |
| K234027 | embecta Insulin Delivery System | embecta medical I LLC | QFG | Class II | |
| K233932 | Alinity i Toxo IgM | Abbott Medical | LGD | Class II | |
| K233872 | Daylight | Big Health Inc | SCP | Class II | |
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation | OWB | Class II | |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare Ltd. | GZJ | Class II | |
| K231969 | BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | Dongguanshi Yiyingmei Technology Co., Ltd. | HGX | Class II | |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | GXY | Class II | |
| K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) | Ortho-Design | MBI | Class II | |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips | Howmedica Osteonics Corp | MQV | Class II | |
| K242243 | Target Detachable Coils | Stryker Neurovscular | HCG | Class II | |
| K241881 | IPL Hair Removal Device (JM-843, JM-865, JM-638) | Shenzhen Junmei Technology Co., Ltd. | OHT | Class II | |
| K241400 | SkinPen Precision Elite System | Crown Aesthetics | QAI | Class II | |
| K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | DQK | Class II | |
| K240105 | Navigator (FMNVG15); Navigator XL (FMNVX06) | Forcemech International LLC. | ITI | Class II |