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 |
|---|---|---|---|---|---|
| K213146 | Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen | Jiangsu Rongye Technology Co.,Ltd | JKA | Class II | |
| K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co.,Ltd | NGL | Class II | |
| K233234 | PressON Spinal Fixation System | Nexus Spine, L.L.C. | NKB | Class II | |
| K233223 | OGmend® Implant Enhancement System | woven Orthopedic Technologies | QVI | Class II | |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. | GXH | Class II | |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Spectrum Medical Inc | KFM | Class II | |
| K232500 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K232271 | SIMDA abutment | Simda Co.,Ltd. | NHA | Class II | |
| K231737 | ANAX™ 5.5 Spinal System | Innosys Co., Ltd. | NKB | Class II | |
| K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K231595 | Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. | HGX | Class II | |
| K231579 | Molli 2 | Molli Surgical, Inc. | NEU | Class II | |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | QUH | Class II | |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co.,Ltd. | LZA | Class I | |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | MEDLINE INDUSTRIES, LP - Northfield | BTT | Class II | |
| K230500 | Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | Jiangsu Maxf Electric Appliance Co.,Ltd | IRP | Class II | |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | ETN | Class II | |
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems | PFW | Class II | |
| K233147 | PiXel8-RF | Rohrer Aesthetics, Inc. | GEI | Class II | |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co.,Ltd | KNS | Class II | |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corp. | JWH | Class II | |
| K232436 | Rapid SDH | Ischemaview, Inc. | QAS | Class II | |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | Magstim Inc. | OBP | Class II | |
| K231995 | AcuityUDR | RadmediX, LLC | KPR | Class II | |
| K231327 | POWERSEAL Sealer and Divider | Gyrus ACMI, Inc. | GEI | Class II | |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | NKB | Class II | |
| K230842 | SignalHF (IM008) | Implicity | QNL | Class II | |
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical Ltd. | KKX | Class II | |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | IYO | Class II | |
| K230284 | Penumbra LP Coil System | Penumbra Inc. | HCG | Class II | |
| K222997 | VVR Generator system | Starmed Co.,Ltd | GEI | Class II | |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | |
| K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. | DZE | Class II | |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | MOS | Class II | |
| K233185 | MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System | C2Dx, Inc. | GEI | Class II | |
| K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Corp. | MBI | Class II | |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | DWJ | Class II | |
| K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | K&J Consulting Corp. | NKB | Class II | |
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | |
| K232570 | Steerant™ Super Stiff Guidewire | Medtronic, Inc. | DQX | Class II | |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | OAP | Class II | |
| K232223 | PlaDuo System | ShenB Co., Ltd. | GEI | Class II | |
| K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | OUR | Class II | |
| K232086 | spineEOS | EOS imaging | LLZ | Class II | |
| K232051 | VISULAS green | Carl Zeiss Meditec Inc | HQF | Class II | |
| K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | IYN | Class II | |
| K230919 | Acumen IQ finger cuff | Edwards Lifesciences LLC | DXN | Class II | |
| K230472 | Sonopuls 190 | Enraf-Nonius B.V. | IMI | Class II |