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 |
|---|---|---|---|---|---|
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | GXP | Class II | |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | Paragon 28 | HWC | Class II | |
| K231152 | Collagen Wound Dressing | Winner Medical Co., Ltd. | KGN | Unclassified | |
| K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | HSN | Class II | |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | FYA | Class II | |
| K230650 | Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co., Ltd. | GEI | Class II | |
| K222222 | Artemis, Artemis TPO, Artemis MX | Eigen | QTZ | Class II | |
| DEN200076 | ORi | Masimo Corporation | QWE | Class II | |
| K233233 | EMPHASYS Femoral Stems | Depuy Ireland UC | LZO | Class II | |
| K232981 | Synq Software Version 1.3 | Synaptive Medical Inc | LNH | Class II | |
| K232578 | Vassallo Gt 018 G12; Vassallo Gt 018 G30 | Filmec Co., Ltd. | DQX | Class II | |
| K232574 | VASSALLO GT Crossing14 | Filmec Co., Ltd. | DQX | Class II | |
| K232499 | IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | OHT | Class II | |
| K232460 | Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. | GEI | Class II | |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | GE Medical Systems SCS | OWB | Class II | |
| K232090 | JO Coconut Hybrid Warming Personal Lubricant | CC Wellness LLC | NUC | Class II | |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K231050 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc | DXN | Class II | |
| K230897 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | DZE | Class II | |
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K230148 | Vlab | Dormotech Medical Inc. | GWL | Class II | |
| K230116 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | NKB | Class II | |
| K223126 | SurgiAid® Collagen Wound Dressing | Maxigen Biotech, Inc. | KGN | Unclassified | |
| K222025 | G4Derm / G4Derm Plus Synthetic Wound Matrix | GEL4MED, Inc. | FRO | Unclassified | |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | OCC | Class II | |
| K232471 | Vy Spine™ VyLam™ Laminoplasty System | VY Spine, LLC | NQW | Class II | |
| K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K231658 | VEOS Spinal Fixation System | Spineway | NKB | Class II | |
| K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | |
| K230961 | Zeus Spinal System | Shanghai Sanyou Medical Co. Ltd | NKB | Class II | |
| K230916 | WeSensor | PICOPACK Inc. | MUH | Class II | |
| K230130 | Micromate™ Navi+ | ISYS Medizintechnik GmbH | JAK | Class II | |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | IPF | Class II | |
| K232787 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | QRG | Class II | |
| K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc | LNH | Class II | |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex GmbH | HTN | Class II | |
| K232492 | 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor | Medos International SARL | MBI | Class II | |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. | PZS | Class II | |
| K232411 | JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC | MBI | Class II | |
| K232407 | Cautery Protective Actuation System (CPAS) | Safer Surgeries Medical Devices, LLC | GEI | Class II | |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | JTN | Class II | |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | MQP | Class II | |
| K232056 | IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 | Dongguan Lide Electric Appliance Co., Ltd | OHT | Class II | |
| K232055 | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | LHI | Class II | |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company | PIF | Class II | |
| K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | OLO | Class II | |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | LHN | Class II | |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics | OXC | Class II | |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair LGL | PNR | Class II |