Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2019 — Predicate Candidate Screening
2,918 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
120 daysmedian FDA review time
281 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193381 | RadCalc Software | Lifeline Software, Inc. | 2019-12-31 | 26 | 0 |
| K192912 | AutoMIStar | Apollo Medical Imaging Technology Pty. , Ltd. | 2019-12-31 | 77 | 0 |
| K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019-12-31 | 103 | 0 |
| K192343 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2019-12-31 | 125 | 0 |
| K190990 | Digital Thermometer | Xiamen Ants Bro Technology Co., Ltd. | 2019-12-31 | 260 | 0 |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | Mercator Medical (Thailand), Ltd. | 2019-12-31 | 116 | 0 |
| K192258 | Disposable Valve Sets | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 | 132 | 0 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-12-30 | 96 | 0 |
| K190241 | Sterile Latex Surgical Glove, Powder Free | Careglove Global Sdn. Bhd. | 2019-12-30 | 327 | 0 |
| K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-12-27 | 249 | 0 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesi | Cook Biotech Incorporated | 2019-12-27 | 185 | 0 |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019-12-27 | 70 | 0 |
| K193149 | True 3D Viewer Software | Echopixel, Inc. | 2019-12-27 | 44 | 0 |
| K192700 | Xcam | Hdx Will Corp. | 2019-12-27 | 92 | 0 |
| K193403 | UroNav System | Invivo Corporation | 2019-12-27 | 21 | 0 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | 2019-12-27 | 231 | 0 |
| K192196 | Medical Radiation Dosimetry System microSTARii | Landauer | 2019-12-27 | 136 | 39 |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD , Ltd. | 2019-12-27 | 92 | 0 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 | 87 | 0 |
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And De | Datascope Corp. | 2019-12-26 | 266 | 0 |
| K190467 | iHelmet Hair Growth System | Slinph Technologies Co., Ltd. | 2019-12-26 | 303 | 0 |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymull | Zimmer GmbH | 2019-12-26 | 55 | 0 |
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VI | MicroVention, Inc. | 2019-12-24 | 139 | 0 |
| K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019-12-23 | 26 | 0 |
| K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | Umeheal , Ltd. | 2019-12-23 | 87 | 0 |
| K191960 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2019-12-23 | 153 | 0 |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Diversatek Healthcare, Inc. | 2019-12-23 | 371 | 0 |
| K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 | 277 | 0 |
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019-12-23 | 166 | 0 |
| K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019-12-23 | 147 | 0 |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019-12-23 | 104 | 0 |
| K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019-12-23 | 451 | 0 |
| K192487 | EZ-TRAX Containment Device | K1 Medical, LLC | 2019-12-23 | 103 | 0 |
| K191551 | RIST Cath Radial Access Long Sheath | Rist Neurovascular, Inc. | 2019-12-23 | 194 | 0 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 | 90 | 0 |
| K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019-12-23 | 27 | 0 |
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For | Ever Growth (Vietnam) Co. , Ltd. | 2019-12-23 | 265 | 0 |
| K190665 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-23 | 283 | 0 |
| K192104 | Medline Sterile Power-Free Nitrile Examination Gloves - Blue | Medline Industries, Inc. | 2019-12-23 | 140 | 0 |
| K192629 | Spinalytics | Optima Health Solutions International Corp. | 2019-12-21 | 89 | 0 |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019-12-21 | 95 | 0 |
| K193230 | Ziehm Vision FD | Ziehm Imaging GmbH | 2019-12-20 | 25 | 0 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 | 312 | 0 |
| K192711 | Dannik Titanium Ligation Clip | Dannik | 2019-12-20 | 84 | 0 |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | 2019-12-20 | 283 | 0 |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies | 2019-12-20 | 204 | 0 |
| K193018 | Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. | 2019-12-20 | 52 | 0 |
| K192833 | Indigo Aspiration System | Penumbra, Inc. | 2019-12-20 | 79 | 0 |
| K193292 | Voyant 5mm Fusion Device, Voyant Maryland Fusion Device | Applied Medical Resources Corp. | 2019-12-20 | 23 | 0 |
| K192990 | Litho Evo | Quanta System Spa | 2019-12-20 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda