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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K152671 | Pulse Aloe-ahh | Toaster Labs, Inc. | NUC | Class II | |
| K152628 | Pulse H20h! | Toaster Labs, Inc. | NUC | Class II | |
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Prosurg, Inc | HRX | Class II | |
| K152166 | JSM Insulin Pen Needle | Jeesung Medical Co., Ltd. | FMI | Class II | |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | GXI | Class II | |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics Corp. | DRE | Class II | |
| K161238 | S-scan | Esaote S.p.A. | LNH | Class II | |
| K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | LZO | Class II | |
| K161089 | sensiLight Mini | El Global Trade Ltd. | OHT | Class II | |
| K160978 | LITe BIO Delivery System | Stryker Corp. | FMF | Class II | |
| K160896 | Ultrashape Power System | Syneron Medical, Ltd. | OHV | Class II | |
| K160715 | AccuLIF TL and PL Cage | Stryker Corp. | MAX | Class II | |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | Aesculap Inc | OLO | Class II | |
| K153357 | i-STAT Alinity System with i-STAT Sodium test | Abbott Medical | JGS | Class II | |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory Co. | LCO | Class II | |
| K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | OYH | Class II | |
| K152920 | Savannah-T® Pedicle Screw System | Spinal Elements, Inc | NKB | Class II | |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | Medtronic Navigation, Inc | GEI | Class II | |
| K152622 | Alta ACDF System | Highridge Medical, LLC | OVE | Class II | |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | ILY | Class II | |
| K151870 | Bd U-500 Insulin Syringe | Becton Dickinson & Co | FMF | Class II | |
| K161305 | Habib EUS RFA | Emcision, Ltd. | GEI | Class II | |
| K160722 | CorticaLINK Spinal Fusion Platform | Facetlink dba Linkspine | NKB | Class II | |
| K160088 | Cydar EV | Cydar, Ltd. | OWB | Class II | |
| K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | OLO | Class II | |
| K153234 | AirLife Adult Heated Wire Circuit | CareFusion 303, Inc | BZE | Class II | |
| K152564 | Gemini Sterilization Wrap | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K161553 | BD SafeAssist | Becton Dickinson & Co | FMI | Class II | |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | KXK | Class II | |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal S.A. | IZL | Class II | |
| K161314 | Flexicare Fl-9000U Respiratory Humidifier Base | Flexicare Medical Ltd. | BTT | Class II | |
| K161296 | Cool Renewal | Cool Renewal, LLC | GEH | Class II | |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co., Ltd. | DJC | Class II | |
| K161012 | Easy-Load Lens Delivery System | Bausch & Lomb Incorporated | MSS | Class I | |
| K160997 | Gc85a | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Dunamis, LLC | MBI | Class II | |
| K160956 | LD-Oxi system | LD Technology LLC | MWI | Class II | |
| K160830 | Integra External Fixation System | Ascension Orthopedics, Inc. | KTT | Class II | |
| K160569 | NeuGuide | Pop Medical Solutions | PBQ | Class II | |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K160439 | SunTech CT40 Spot-check Vital Signs Device | Suntech Medical, Inc. | DXN | Class II | |
| K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | MLR | Class II | |
| K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America Inc. | EMA | Class II | |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | Medtronic, Inc. | LZH | Class II | |
| K153017 | Voyant Fine Fusion | Applied Medical Resources Corp | GEI | Class II | |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System | USA Laser Biotech, Inc. | ILY | Class II | |
| K160607 | PicoWay Laser System | Syneron Candela Corporation | GEX | Class II | |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp | DYB | Class II | |
| K153399 | LightStim Professional LED Bed | LED Intellectual Properties LLC | ILY | Class II | |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics, Inc. | LIP | Class II |