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 |
|---|---|---|---|---|---|
| K080586 | Olympus Xchf Type B180y1 | Olympus Medical Systems Corp. | FBN | Class II | |
| K080397 | American Dental Implant Abutment System | American Dental Implant Corporation | NHA | Class II | |
| K080050 | Spirus Medical Endo-Ease Endoscopic Overtube | Spirus Medical, LLC | FED | Class II | |
| K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | MQV | Class II | |
| K073493 | Hepatostat Set | Vygon Corp. | GAM | Class II | |
| K072259 | Ophthalmoscope F-10 | Nidek Co., Ltd. | MYC | Class II | |
| K081181 | Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser | Cynosure, LLC | GEX | Class II | |
| K081066 | Brachytherapy Source Device, Model 9011 | GE Heathcare, Inc. | IWG | Class II | |
| K081031 | Endoscopic Clip Appliers with Clip Magazine | Aesculap Inc | FZP | Class II | |
| K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement | Tyco Healthcare Group LP | GDW | Class II | |
| K080605 | Sure-Lock Electrode Clip, Model Cl-34, Cl-A60, Cl-Hw, Cl-Tl | Curbell Electronics, Inc. | DSA | Class II | |
| K080509 | Cardioblate 68000 Gnerator, Bp2 Surgical Ablation Device, Lp Surgical Ablation Device, Gemini-Ssurgical Ablation Device | Medtronic, Inc. | OCL | Class II | |
| K073454 | Fingertip Pulse Oximeter, Model Cms-50C | Contec Medical System Co., Ltd. | DQA | Class II | |
| K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory Co. | GKP | Class II | |
| K081185 | Moblvac W.c. | Ohio Medical LLC | BTA | Class II | |
| K081143 | Biomers Translucent Orthodontic Wire | Biomers Product, LLC | DYW | Class II | |
| K081118 | Noras Mr-Bi320-Pa 1.5T | NORAS MRI products GmbH | MOS | Class II | |
| K081109 | Coronis 5Mp Mammo Sl, Model Mdmg 6121 | Barcoview, Medical Imaging Systems | LLZ | Class II | |
| K081104 | Aeskulisa Ana Hep-2, Ref 30-7115Us | Aesku Diagnostics | LKJ | Class II | |
| K081079 | Contura Mlb Source Applicator for Brachytherapy | Senorx, Inc. | JAQ | Class II | |
| K081030 | Modification to Proflu+ Assay | Prodesse, Inc. | OCC | Class II | |
| K081005 | P.004 Nc Cares Titanium and Ceramic Abutments | Straumann USA, LLC | NHA | Class II | |
| K081004 | Protectiscope Cs Colonoscope, Non-Intrapull | Stryker GI | FDF | Class II | |
| K080989 | Universal Vial Access Spike | Abbott Medical | FMF | Class II | |
| K080981 | Ear Thermometer, Models St66 and St67 | Mesure Technology Co., Ltd. | FLL | Class II | |
| K080967 | Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe or Trufill Dcs Syringe II, Also Known as the Trufill Dcs Orbit | Cordis Neurovascular, Inc. | HCG | Class II | |
| K080963 | Dss Stabilization System | Paradigm Spine GmbH | NQP | Class II | |
| K080911 | Variant Nbs Sickle Cell Program Reagent Kit, Variant Nbs Newborn Screening System and Variant Nbs Workstation with | Bio-Rad Laboratories Inc., Clinical Systems Divisi | GKA | Class II | |
| K080887 | Sysmex Uf-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software | Sysmex America, Inc. | LKM | Class II | |
| K080646 | C-Tek Maxan Anterior Cervical Plate System | Highridge Medical, LLC | KWQ | Class II | |
| K080645 | Std Med Primo Port Poly | Std Med, Inc. | LJT | Class II | |
| K080556 | Artbloc Temp, Dimension: 15.5 X19.39 Mm V-Classic Shades and Bleach Shades | Merz Dental GmbH | EBG | Class II | |
| K080383 | Aquacel Hydrofiber Wound Dressing and Ag Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons | FRO | Unclassified | |
| K080158 | Lb Medical Inflatable Tissue Elevator/expander System | Lb Medical LLC | FZW | Class I | |
| K080118 | Zeltiq Aesthetics Cln1 Dermal Cooling Device | Zeltiq Aesthetics Inc | GEX | Class II | |
| K080093 | Pks Plasma Morcellator, Models 962000Pk, 3620Pk | Gyrus ACMI, Inc. | GEI | Class II | |
| K080065 | Osferion | Olympus Terumo Biomaterials Corporation | MQV | Class II | |
| K073543 | Oec 9900 Elite | GE Healthcare | OWB | Class II | |
| K073281 | Cais Staple | DePuy Mitek, Inc. | JDR | Class II | |
| K073192 | Powdered Vinyl Patient Examination Gloves | Shijiazhuang Prosperous Plastic Co., Ltd. | LYZ | Class I | |
| K072696 | Ant Angiographic Syringes, Model(s) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | DXT | Class II | |
| K071642 | Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse Oximeter | Mediaid, Inc. | DQA | Class II | |
| K081120 | Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials | Kettenbach GmbH & Co KG | ELW | Class II | |
| K081093 | 3-D Imaging Workstation | Eigen | LLZ | Class II | |
| K081071 | Synthes 6.5Mm Midfoot Fusion Bolt | Synthes (USA) Products LLC | HWC | Class II | |
| K080568 | X-Mesh Expandable Cage System | DePuy Spine, Inc. | MQP | Class II | |
| K080307 | Prochem Indicator Tape | Raven Laboratories | JOJ | Class II | |
| K080281 | Pathway | Custom Spine, Inc. | MAX | Class II | |
| K073532 | Disposable Adhesive Surface Electrodes, Disc Electrodes | Technomed Europe | GXY | Class II | |
| K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space | Aesculap Inc | MAX | Class II |