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 |
|---|---|---|---|---|---|
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics Inc. | JDI | Class II | |
| K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | |
| K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | NXC | Class II | |
| K180216 | Seidmon Antegrade AQ Stent Set | Cook Incorporated | FAD | Class II | |
| K180068 | ORISE Gel | Boston Scientific Corporation | PLL | Class II | |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | PCH | Class II | |
| K173872 | FibriCheck | Qompium NV | DXH | Class II | |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories Co., Ltd. | KSB | Class II | |
| DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies | QDC | Class II | |
| K182402 | CoLink View Plating System | In2bones USA, LLC | HRS | Class II | |
| K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K182370 | Acculoc Total Knee System | Rootloc Co., Ltd. | JWH | Class II | |
| K181975 | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 | Oxoid Limited (Part of Thermo Fisher Scientific) | JTN | Class II | |
| K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker Corp. | KWS | Class II | |
| K181608 | Disposable Standard Clamp | Standard Bariatrics | GCJ | Class II | |
| K181397 | DualX | Innovasive, Inc. | MAX | Class II | |
| K181075 | PureSet Tray | Nobel Biocare AB | KCT | Class II | |
| K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | KRD | Class II | |
| K173833 | CRP Vario | Sentinel CH SpA | NQD | Class II | |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | Hardy Diagnostics | JTN | Class II | |
| K182325 | InMode RF System | Inmode MD, Ltd. | GEI | Class II | |
| K182315 | Magic Torque DLVR Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K181991 | NxStage Connected Health System | NxStage Medical Inc | FKP | Class II | |
| K181707 | Everyway Wireless TENS & EMS Unit | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC | MAX | Class II | |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | Access Scientific, Inc. | DQY | Class II | |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K180803 | BeautiBond Universal | Shofu Dental Corp. | KLE | Class II | |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CGA | Class II | |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K182290 | IBM iConnect Access | Merge Healthcare Incorporated | LLZ | Class II | |
| K181980 | OsseoScrew System | Alphatec Spine, Inc. | NKB | Class II | |
| K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | LJS | Class II | |
| K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan AST Medical Equipment Co., Ltd | IOR | Class I | |
| K181773 | Synapse 3D Optional Tools | FUJIFILM Corporation | LLZ | Class II | |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) | Health Beacons, Inc. | NEU | Class II | |
| K181424 | PeDIA | Pedia | BTC | Class I | |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | LCP | Class II | |
| K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm und Rehbein GmbH | IZL | Class II | |
| K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | PHX | Class II | |
| K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | LPH | Class II | |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon, Inc. | LLZ | Class II | |
| K180714 | Probe Covers for Thermometers | K-Jump Health Co., Ltd. | FLL | Class II | |
| K182345 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | |
| K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | LLZ | Class II | |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm | United States Endoscopy Group, Inc. | FEQ | Class II | |
| K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | Hebei Titans Hongsen Medical Technology Co.,Ltd | LYZ | Class I | |
| K181926 | InVivo Web Viewer | Anatomage, Inc. | LLZ | Class II | |
| K181789 | VeriSuite | Medcom GmbH | LHN | Class II | |
| K181769 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II |