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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | PAH | Class II | |
| K073663 | Gelspray Wound Dressing | Biocure, Inc. | KMF | Class I | |
| K073573 | Wavesense Keynote Codeless Blood Glucose Monitoring System | Agamatrix | NBW | Class II | |
| K073413 | Depuy Asr 300 Acetabular Cup System | Depuy Orthopaedics Inc. | KWA | Class III | |
| K073267 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | NKB | Class II | |
| K073202 | Ardis Spacer | Spinal Concepts, Inc. | MAX | Class II | |
| K073139 | Small Lumen Peritoneal Catheter | Medtronic Neurosurgery | JXG | Class II | |
| K073004 | Somnomed Bflex | Somnomed Inc. | LRK | Class II | |
| K072608 | Lyophilized Multiblast Medium Kit | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | LNS | Class II | |
| K072381 | Softpap Cervical Cell Collector | Cytocore, Inc. | HHT | Class II | |
| K072257 | Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-Level | More Diagnostics Inc. | LAS | Class I | |
| K072252 | Veinoplus Neuromuscular Stimulator | Ad Rem Technology SARL | IPF | Class II | |
| K071778 | Hero Vascular Access Device | Graftcath, Inc. | DSY | Class II | |
| K070514 | Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit, Precurved Extractio | Aln Implants Chirurgicaux | DTK | Class II | |
| K080019 | Hardydisk Ast Doripenem 10 Ug | Hardy Diagnostics | JTN | Class II | |
| K073719 | Asc Triport Laparoscopic Access Device | Advanced Surgical Concepts | GCJ | Class II | |
| K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | Depuy Orthopaedics Inc. | PHX | Class II | |
| K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | NKB | Class II | |
| K073275 | Nuvasive Helix Mini Acp System | NuVasive Inc | KWQ | Class II | |
| K073209 | Maxcem 2 | Sybron Dental Specialties, Inc. | MZW | Class II | |
| K073135 | Synthes (USA) Hybrid External Fixator Modifications | Synthes (USA) Products LLC | LXT | Class II | |
| K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models De19sh24, De23sh28, De27sh32, De31sh36, De35sh40, | Spire Biomedical, Inc. | MSD | Class II | |
| K072760 | Solcart B | B. Braun Medizintechnologie GmbH | KPO | Class II | |
| K062534 | Enzyme Immunoassay for the Detection of Salivary 17-a-Hydroxyprogesterone | Drg Intl., Inc. | JLX | Class I | |
| K080075 | Modification to: Vertefix Pedicle Screw Spinal System | Elite Surgical Supplies (Pty) Ltd | MNI | Class II | |
| K080026 | Quantum-Mis Cannulated System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MNI | Class II | |
| K073701 | Dane Technologies Wheelchair Mover, Model Wm 2000 | Dane Technologies | ITI | Class II | |
| K073655 | Pegasus Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | DQX | Class II | |
| K073233 | Orthoglide Lateral Knee Implant and Instruments | Advanced Bio-Surfaces, Inc. | HSH | Class II | |
| K072989 | Axis System | Dentsply Intl. | EFB | Class I | |
| K072967 | Quanta Lite F-Actin Iga Elisa | Inova Diagnostics, Inc. | MVM | Class II | |
| K072943 | Butrex Buttress Plating System | Xtant Medical Holdings, Inc. | KWQ | Class II | |
| K072114 | Impulse 6000D/7000dp | Fluke Biomedical | DRL | Class II | |
| K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | JOJ | Class II | |
| K073670 | Kodak Point of Care Cr 120, Kodak Point of Care Cr 140, Kodak Point of Care Cr 260 | Orex Computed Radiography, Ltd. | MQB | Class II | |
| K073665 | Algo 5 Newborn Hearing Screener | Bio-Logic Systems Corp. | GWJ | Class II | |
| K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System | Hypermed, Inc. | MUD | Class II | |
| K073649 | Bengal Stackable Cage System | DePuy Spine, Inc. | MQP | Class II | |
| K073625 | Modification to: Mac 5500 Resting ECG Analysis System | GE Healthcare Systems Information Technologies | DPS | Class II | |
| K073461 | Ortho Anchor Screws | MIS Implants Technologies Ltd. | OAT | Class II | |
| K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector | Kawasumi Laboratories Co., Ltd. | FMI | Class II | |
| K073069 | Modification to Avea Ventilator | ZOLL Palm Springs | CBK | Class II | |
| K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | FPA | Class II | |
| K072887 | G-Trainer Medical | Alter-G, Inc. | BXB | Class I | |
| K072754 | Axenic Dhp Disposable High-Performance Handpiece | Axenic Dental, Inc. | EFB | Class I | |
| K072753 | Reusable, Disposable Laparoscopic Instrument and Surgical Device and Accessories | RG Medical USA | HIF | Class II | |
| K072647 | Glycerin & Paraben Free Astroglide | Biofilm, Inc. | NUC | Class II | |
| K072607 | Lyophilized Early Cleavage Medium (Ecm) Kit | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K072415 | Stalif (Tm) C | Surgicraft, Ltd. | OVE | Class II |