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 |
|---|---|---|---|---|---|
| K081630 | Mammo Workstation | Image Diagnost International GmbH | LLZ | Class II | |
| K081524 | Spectra-Lor, 10 Ml Plastic Loss of Resistance Syringe, L/s, Spectra-Lor, 10Ml Plastic Loss of Resistance Syringe L/l | Spectra Medical Devices, LLC | FMF | Class II | |
| K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), Calibrators | Siemens Healthcare Diagnostics Inc. | NQD | Class II | |
| K081238 | Reprocessed Masimo Pulse Oximeter Sensors | Stryker Sustainability Solutions | NLF | Class II | |
| K081112 | Flexiplan Brachytherapy Treatment Planning System | Isodose Control B.V. | MUJ | Class II | |
| K080939 | Surgical Handpieces, Mikro Saw Handpieces | W & H DentalWerk Buermoos GmbH | KMW | Class II | |
| K080426 | Maestro Wrist Fracture Implant | Biomet Manufacturing Corp | JWJ | Class II | |
| K073089 | Lifepak 20E | Physio Control, Inc. | MKJ | Class III | |
| K082014 | Stryker Spine Avs Pl Peek Spacers | Stryker Corp. | MAX | Class II | |
| K081976 | Impax Ma3000 Diagnostic Pacs Workstation | AGFA Healthcare Corp. | LLZ | Class II | |
| K081583 | Clearfil Sa Cement | Kuraray Medical, Inc. | EMA | Class II | |
| K081561 | Osferion D | Olympus Terumo Biomaterials Corporation | LYC | Class II | |
| K081497 | Opus Magnum2 Knotless Fixation Device (Model Om-1502), Opus Magnum X Knotless Fixation Device (Model Om-1503) | ArthroCare Corporation | MBI | Class II | |
| K081430 | Elekta Neuromag with Maxwell Filter with Internal Active Shielding | Elekta Neuromag Oy | OLX | Class II | |
| K081233 | T-Stat 303 Ischemia Monitoring System | Spectros Corporation | MUD | Class II | |
| K081206 | Homelox | Respironics, Inc. | CAW | Class II | |
| K081176 | Flochannel | Chad Therapeutics, Inc. | MNR | Class II | |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K081129 | Enseal Powertip,nseal-514D,-525D,-535D,-545D,-514Rd,-525Rd,-535Rd,-545Rd, Etrio-314D,-325D,-335D,-345D, Enseal Universal | Surgrx, Inc. | GEI | Class II | |
| K080220 | Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device | Italia Medica S.r.l. | DZI | Class II | |
| K080178 | Valvulotome by Koven | Koven Technology, Inc. | MGZ | Class II | |
| K080092 | Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol Thyroab | Roche Diagnostics GmbH | JZO | Class II | |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: Mp0500g | DiaSorin Molecular LLC | LSE | Class I | |
| K081963 | Agfa Computed Radiography Systems with Nx2008 Workstations | AGFA Healthcare Corp. | MQB | Class II | |
| K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads, Models I30v, I45v, 160V, Ir30v | Power Medical Interventions, Inc. | GDW | Class II | |
| K081718 | Express Chest Drain | Atrium Medical Corporation | KDQ | Class II | |
| K081714 | Fora Td-3224 Blood Glucose Plus Blood Pressure Monitoring System | Taidoc Technology Corporation | CGA | Class II | |
| K081506 | Hyperbaric America, Llc, Presidential Monoplace Hyperbaric Chamber Systems | Hyperbaric America, LLC | CBF | Class II | |
| K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | JJX | Class I | |
| K080969 | Healthline Redi-Neb Medication Nebulizer, Model Rn-510 | Medi Nuclear Corp., Inc. | CAF | Class II | |
| K080922 | Salter Labs Oral/nasal Thermal Airflow Sensor | Salter Labs, Division of Regulatory Affairs | BZQ | Class II | |
| K080849 | Microsheath Lp and Lp-at | Flowcardia, Inc. | DQY | Class II | |
| K080848 | Alcohawk Model Pt500 Digital Alcohol Detector | Q3 Innovations, LLC | DJZ | Class I | |
| K080664 | Relieve Laminoplasty Fixation System | Globus Medical, Inc. | NQW | Class II | |
| K080468 | Liasys with Models Liasys | Ams S.r.l. Analyzer Medical System | CFR | Class II | |
| K080292 | Epicor Ablation System | Abbott Medical | OCL | Class II | |
| K073249 | Solaris Nt1 and Nt1a Handheld Pulse Oximeters with Sensor Accessories | Solaris Medical Technology, Inc. | DQA | Class II | |
| K081790 | Modification to Single Planar Multi Axis (Spma) Pedicle Screw System | Trinity Orthopedics, LLC | MNI | Class II | |
| K081431 | Meg Laparoscopic Electrodes | Apyx Medical Corporation | GEI | Class II | |
| K081351 | Modification to Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | HSX | Class II | |
| K081325 | Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 Ug/ml | Ab Biodisk | JWY | Class II | |
| K080814 | Voco Profluorid Varnish | Voco GmbH | LBH | Class II | |
| K080545 | Actitrainer | ActiGraph L.L.C. | ISD | Class II | |
| K080357 | Medela Invia Wound Therapy | Medela AG | OMP | Class II | |
| K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | FTL | Class II | |
| K081593 | Power Aspirator, Model Ls2 or Ls2dp | Medical Device Resource Corp. | QPB | Class II | |
| K081353 | Synthes (USA) Tomofix Medial Distal Femur Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K081331 | Fixxsure Cross Link | Spineworks, LLC | MNH | Class II | |
| K081177 | Blackstone Medical, Inc., Pillar Spacer System | Blackstone Medical, Inc. | MAX | Class II | |
| K081111 | Legion Hinge Knee System | Smith & Nephew, Inc. | KRO | Class II |