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 |
|---|---|---|---|---|---|
| K162403 | HyperBand | GE Healthcare | LNH | Class II | |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | Viora, Ltd. | GEX | Class II | |
| K162230 | Fully Automatic Electronic Blood Pressure Monitor | Adon Health Co., Ltd. | DXN | Class II | |
| K162198 | GFS Ultimate | Parcus Medical, L.L.C. | MBI | Class II | |
| K162160 | Preference Elite Pedicle Screw System | Amedica Corp. | NKB | Class II | |
| K162078 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K161795 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K161673 | LacriPro Punctum Plug | Lacrimedics, Inc. | LZU | Unclassified | |
| K161472 | Walk-O2-Bout | Essex Industries, Inc | ECX | Class I | |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | IYX | Class I | |
| K160595 | PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator | Pms Medikal Ambalaj Sanayi ve Ticaret Ltd Sti | FRG | Class II | |
| K160558 | Rapido Hollow-Fibre Dialyzers | BELLCO SRL | KDI | Class II | |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator | Diazyme Laboratories, Inc. | DFH | Class II | |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | DIO | Class II | |
| K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Healthcare | IYN | Class II | |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DWB | Class II | |
| K162583 | Aloka Lisendo 880 | Hitachi, Ltd. | IYN | Class II | |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K162431 | Luna 3D Interbody Fusion System | Benvenue Medical, Inc. | MAX | Class II | |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | Access Scientific, Inc. | DYB | Class II | |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | IMJ | Class II | |
| K162232 | MOSS 100 Pedicle Screw System | BIEDERMANN MOTECH GmbH & Co. KG | NKB | Class II | |
| K162163 | UltraShape System | Syneron Medical, Ltd. | OHV | Class II | |
| K162097 | InTRAkit | Medtronic, Inc. | DYB | Class II | |
| K161978 | AirFit N20 | ResMed Corp | BZD | Class II | |
| K161939 | Avance Abdominal Dressing Kit | Molnlycke Health Care, US LLC | OXJ | Class II | |
| K161909 | IQvitals Zone | Midmark Corp | MWI | Class II | |
| K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | GDW | Class II | |
| K161735 | Non-contact Forehead Thermometer | Shenzhen Dongdixin Technology Co., Ltd. | FLL | Class II | |
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Shen Wei (USA), Inc. | LZA | Class I | |
| K160959 | Xsert Lumbar Expandable Interbody System | Xtant Medical Holdings, Inc. | MAX | Class II | |
| K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | JDI | Class II | |
| K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | |
| K160564 | TroClose1200 | Gordian Surgical | GAM | Class II | |
| K160045 | Heyman Packing Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K163020 | Xperius Ultrasound System | Philips Health Care | IYN | Class II | |
| K162914 | VenaCure EVLT NeverTouch Procedure Kit | Boston Scientific Corporation | GEX | Class II | |
| K162541 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | EBF | Class II | |
| K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K162231 | iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert | Cyden Limited | OHT | Class II | |
| K162210 | touchTymp | MAICO Diagnostics GmbH | ETY | Class II | |
| K161999 | Aixplorer | Supersonic Imagine | IYN | Class II | |
| K161692 | Diode Laser Therapy Machine | Beijing Adss Development Co., Ltd. | GEX | Class II | |
| K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw | Tyber Medical | HWC | Class II | |
| K161288 | LenSX Laser System | Alcon Laboratories | OOE | Class II | |
| K160800 | DuoCem | Coltene /Whaledent AG | EMA | Class II | |
| K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | Evolution Spine, LLC | MAX | Class II | |
| K162990 | Optima XR240amx | GE Healthcare | IZL | Class II | |
| K162894 | AccuCath Intravascular Catheter | C.R. Bard Inc | FOZ | Class II |