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 |
|---|---|---|---|---|---|
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | Cook Medical LLC | DYB | Class II | |
| K240329 | Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F) | Yongkang Youha Electric Appliance Co., Ltd. | ITI | Class II | |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) | Hong Kong Etech Groups Limited | NUH | Class II | |
| K234085 | LUNE™ PureHygiene | Enamel Pure Inc. | GEX | Class II | |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical,Inc. | GWF | Class II | |
| K233919 | VariAx 2 Distal Radius System | Stryker Corp. | HRS | Class II | |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | Gyrus ACMI, Inc. | FGB | Class II | |
| K233167 | LW Implant System – Abutment | Ossvis Co., Ltd. | NHA | Class II | |
| K232268 | STERI-OSS Implant System | Zeros Co., Ltd. | DZE | Class II | |
| K231986 | Modus IR | Synaptive Medical Inc | IZI | Class II | |
| K240715 | Idys® C ZP 3DTi | Clariance, Inc. | OVE | Class II | |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine LLC | KWQ | Class II | |
| K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K240522 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | BTO | Class II | |
| K233578 | Bahadir Sterilization Containers | Bahadir USA LLC | KCT | Class II | |
| K233569 | SeptAlign | Spirair, Inc | NHB | Class II | |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | BYI | Class II | |
| K233262 | Dukal SMS Sterilization Wrap | Dukal LLC | FRG | Class II | |
| K233148 | Augment Off-Axis Instrument System | Fix Surgical | PHX | Class II | |
| K232920 | RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | The Ureteral Stent Company, Inc. | FAD | Class II | |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | MSX | Class II | |
| K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | QAS | Class II | |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | DRT | Class II | |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | |
| K232169 | FITBONE® Transport and Lengthening System | Orthofix SRL | HSB | Class II | |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | O&M Halyard, Inc. | LZA | Class I | |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Guangdong Youkey Medical Co., Ltd. | IYN | Class II | |
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics GmbH | CEW | Class II | |
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics Inc. | OBP | Class II | |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | JTN | Class II | |
| K231795 | QuickVue COVID-19 Test | Ortho-Clinical Diagnostics, Inc. | QYT | Class II | |
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs Ltd. | SAL | Class II | |
| K240754 | N2 | Megagen Implant Co., Ltd. | EIA | Class I | |
| K240530 | DynaNail Mini Tapered Hybrid | Medshape, Inc. | HWC | Class II | |
| K240309 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K240253 | Reach Needle | Aerin Medical, Inc. | BSP | Class II | |
| K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co.,Ltd. | GEX | Class II | |
| K240122 | Normatec Elite | Normatec Industries, LP | IRP | Class II | |
| K234081 | RedDrop ONE (One) | Reddrop DX | FMK | Class II | |
| K234062 | APTUS Hand Scaphoid Plates | Medartis AG | HRS | Class II | |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | NGL | Class II | |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | Depuy Ireland UC | KRO | Class II | |
| K233926 | accufit | Mettler Electronics Corp | IPF | Class II | |
| K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | JAK | Class II | |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | DePuy Synthes | HRS | Class II |