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 |
|---|---|---|---|---|---|
| K261544 | Hydro Irrigation System | Stryker Corp. | EOB | Class II | |
| K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access Inc | LJT | Class II | |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K260428 | RIVOS™ EUS Access Device (M00553900) | Boston Scientific Corporation | ODG | Class II | |
| K260006 | INOSS System | Inosys, Inc. | DZE | Class II | |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | GEI | Class II | |
| K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | MRX | Class II | |
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd | MUI | Class II | |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | HSB | Class II | |
| K253055 | Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) | Nordic Kinetics AB | GYD | Class II | |
| K253045 | “Socko” Vimax Spinal Fixation System | Socko Medical Co., Ltd. | NKB | Class II | |
| K252399 | Portable Oxygen Concentrator | HONSUN (NANTONG) Co., Ltd. | CAW | Class II | |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical Inc. | GEI | Class II | |
| K261683 | Augment Off-Axis Instrument System | Zimmer GmbH | PHX | Class II | |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | HRS | Class II | |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd | OAP | Class II | |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K260831 | Z1 Hip System | Zimmer GmbH | LZO | Class II | |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | DXN | Class II | |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek Inc. | NUH | Class II | |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K253723 | Boss | Medpark Co., Ltd. | NPM | Class II | |
| K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | Empirical Spine, Inc. | SGL | Class II | |
| K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | QTZ | Class II | |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | OAP | Class II | |
| K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | FUJIFILM Corporation | EOQ | Class II | |
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | DFC | Class II | |
| K253046 | HERA Interlocking Intramedullary Nailing System | Zhejiang Decans Medical Devices Co.,Ltd. | HSB | Class II | |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | NHJ | Class II | |
| K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | GXP | Class II | |
| K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | |||
| K260482 | DRE Duo | JPI Healthcare Co., Ltd | KPR | Class II | |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd | LXB | Class II | |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | ITI | Class II | |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | DiaSorin Molecular LLC | PGX | Class II | |
| K260300 | WatchMate Software | Anumana Inc. | QIH | Class II | |
| K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave Inc | PML | Class II | |
| K260126 | Curajel™ Oral Gel | Uspharma Ltd | OLR | Unclassified | |
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co., Ltd. | OVE | Class II | |
| K253922 | Neodent Scannable Healing Abutment | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K253825 | Saige-Dx | Deephealth | QDQ | Class II | |
| K253690 | LungMaps | Siemens Healthineers AG | QIH | Class II | |
| K253172 | MediAI-OA | Crescom Co., Ltd. | QIH | Class II | |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | MAX | Class II | |
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | MQE | Class II | |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | DXN | Class II | |
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | GWQ | Class II | |
| K261634 | Disposable Blood Lancet (Soft) | Sterilance Medical (Suzhou) Inc. | QRK | Class II |