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 |
|---|---|---|---|---|---|
| K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences LLC | DXF | Class II | |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex GmbH | HTN | Class II | |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | MUJ | Class II | |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | LJS | Class II | |
| K213109 | Auxilock Draw Tight Suture-Based Anchor | Auxein medical Private Limited | MBI | Class II | |
| K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | FMI | Class II | |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | WRP Asia Pacific Sdn Bhd | LYY | Class I | |
| K201730 | Powered Inflatable Tube Massager - SLIM UP DRAIN | Foggiare Technologies, LLC | IRP | Class II | |
| K222239 | SmartBolus Calculator | Insulet Corporation | QRX | Class II | |
| K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28 | HRS | Class II | |
| K222172 | MI View&GO | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | DQX | Class II | |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Centinel Spine, LLC | QLQ | Class II | |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 | Cipher Surgical Ltd | OCX | Class II | |
| K221403 | Cortera Spinal Fixation System | Surgalign Spine Technologies | NKB | Class II | |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | FUJIFILM Corporation | ODG | Class II | |
| K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | OLO | Class II | |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Spinal Simplicity, LLC | PEK | Class II | |
| K220812 | DynaClip® Bone Staple | Medshape, Inc. | JDR | Class II | |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ulrich medical USA Inc | ODP | Class II | |
| K220394 | SmartAdjust(TM) technology | Insulet Corporation | QJI | Class II | |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd | FBK | Class II | |
| K220193 | BD MAX Enteric Parasite Panel | Becton Dickinson & Co | PCH | Class II | |
| K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | LSR | Class II | |
| K213933 | Percent Oxygen Sensors | Careox, LLC | CCL | Class II | |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.r.l. | FLE | Class II | |
| K213520 | Axir-Cx | Radisen Co Ltd | LLZ | Class II | |
| K212554 | Bonvadis Topical Cream | Stemcyte, Inc. | FRO | Unclassified | |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | LHI | Class II | |
| K203078 | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW | Huizhou Tianchang Industrial Co., Ltd. | FXX | Class II | |
| K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | STERIS Corporation | GEH | Class II | |
| K221520 | Miro3D Wound Matrix | Reprise Biomedical, Inc. | KGN | Unclassified | |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | Spectrum Medical Inc | DWF | Class II | |
| K221213 | EnSite X EP System | Abbott Medical | DQK | Class II | |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | LPH | Class II | |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | Vascular Solutions LLC | DQY | Class II | |
| K213390 | Benchmark BMX96 Access System | Penumbra Inc. | QJP | Class II | |
| K212905 | Sotair Device | Safe Bvm Corporation | BTM | Class II | |
| K212856 | iClean Viral Transport System (VTM-RT kit) | Huachenyang(shenzhen)technology Co., Ltd | JSM | Class I | |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | MEG | Class II | |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | NPK | Class II | |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Tdm Co., Ltd. | MAX | Class II | |
| K221838 | Surgical Face Mask (HNFM0103) | Shanghai Hua en Industrial Co Ltd | FXX | Class II | |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster Inc | DQK | Class II | |
| K220903 | WebCeph | Assemblecircle Corp. | LLZ | Class II | |
| K220897 | Disposable Brain Biopsy Needle 2.0 | Pajunk GmbH Medizintechnologie | HAW | Class II | |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | KOI | Class II | |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II |