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 |
|---|---|---|---|---|---|
| K202005 | NovoFine Plus 32G Tip x 4 mm | Novo Nordisk a/S | FMI | Class II | |
| K203551 | Alphenix, INFX-8000V/B, /S, V9.1 | Canon Medical Systems Corporation | OWB | Class II | |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Aesculap Inc | GEI | Class II | |
| K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | IYE | Class II | |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | Boston Scientific Corporation | FGE | Class II | |
| K203126 | S10 Kirra | ResMed Corp | BZD | Class II | |
| K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | NKG | Class II | |
| K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | OVE | Class II | |
| K202749 | ADAPT for Gamma3 | Stryker Corp. | OLO | Class II | |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | OLI | Class II | |
| K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | NHA | Class II | |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | ArthroCare Corporation | GEI | Class II | |
| K201980 | Infrared Thermometer | Contec Medical Systems Co., Ltd. | FLL | Class II | |
| K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) SAS | OKS | Unclassified | |
| K201555 | EchoGo Pro | Ultromics, Ltd. | POK | Class II | |
| K201250 | SQuEEZ Software | Cardiowise, Inc. | LLZ | Class II | |
| K201185 | microINR System | Iline Microsystems S.L. | GJS | Class II | |
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton Dickinson & Co | FOZ | Class II | |
| K191978 | Fever Garde | Hubdic Co., Ltd. | FLL | Class II | |
| K203303 | Emprint SX Ablation Platform with Thermosphere Technology | Medtronic, Inc. | NEY | Class II | |
| K203222 | PERLA TL Posterior Osteosynthesis System | Spineart SA | NKB | Class II | |
| K203163 | ARx Illiac Spinal Screw System | Life Spine | NKB | Class II | |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | DXT | Class II | |
| K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy-America, Inc. | OWN | Class II | |
| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | OAT | Class II | |
| K201905 | SMR 140° Reverse Humeral Body | Lima Corporate S.p.A. | MBF | Class II | |
| K201594 | Primelase Excellence | High Technology Products, SLU | GEX | Class II | |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | MEDLINE INDUSTRIES, LP - Northfield | LJE | Unclassified | |
| K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | DQK | Class II | |
| K200857 | Electric wheelchair (Model: S7012) | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | pjur group Luxembourg S.A. | NUC | Class II | |
| K200346 | Wrist Type Blood Pressure Monitor | Avita Corporation | DXN | Class II | |
| K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L | Olympus Medical Systems Corp. | EOQ | Class II | |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical Inc. | MPN | Class II | |
| K192770 | S dispensing line | Aea SRL | FMF | Class II | |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd | EBG | Class II | |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | DePuy Synthes | HRS | Class II | |
| K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions | GXN | Class II | |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex GmbH | JDR | Class II | |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products Inc | NEU | Class II | |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker Corp. | KWS | Class II | |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics Ltd | NHA | Class II | |
| K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | FXX | Class II | |
| K202028 | dermalux Flex MD | Aesthetic Technology Ltd | ILY | Class II | |
| K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | LQR | Class II | |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart | MQK | Class II | |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | Intl. Medical Industries | QEH | Class II | |
| K200549 | Lucero Medical Cervical Cage System | Lucero Medical, LLC | ODP | Class II |