Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PGW — Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
161 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | 2026-06-02 | 25 | 0 |
| K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | 2026-03-16 | 167 | 0 |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025-06-20 | 266 | 0 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023-07-21 | 28 | 1 |
| K223734 | ENT EM | Brainlab AG | 2023-04-27 | 135 | 0 |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 | 104 | 0 |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Pl | Stryker Corporation | 2022-07-12 | 89 | 1 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoR | Fiagon GmbH | 2021-07-19 | 82 | 0 |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | 2020-10-09 | 30 | 0 |
| K201174 | TruDi Curette | Acclarent, Inc. | 2020-08-12 | 103 | 0 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Soft | Medtronic Navigation, Inc. | 2020-06-26 | 99 | 0 |
| K193453 | TruDi Probe | Acclarent, Inc. | 2020-03-23 | 101 | 0 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | 2020-03-10 | 62 | 0 |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020-02-21 | 101 | 0 |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | 2020-02-14 | 58 | 0 |
| K192397 | TruDi Navigation System | Biosense Webster | 2020-01-30 | 149 | 1 |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019-05-03 | 60 | 0 |
| K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018-07-20 | 100 | 1 |
| K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018-03-10 | 106 | 0 |
| K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017-09-27 | 114 | 0 |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017-05-19 | 136 | 0 |
| K163416 | Fiagon Navigation – PointerTube Straight and PointerTube Kea | Fiagon GmbH | 2017-02-16 | 73 | 0 |
| K161491 | Scopis Hybrid Navigation System EM | Scopis GmbH | 2017-02-09 | 253 | 0 |
| K162176 | Fiagon Navigation System | Fiagon GmbH | 2016-12-01 | 120 | 0 |
| K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016-10-24 | 126 | 0 |
| K161701 | CARTO ENT System | Biosense Webster | 2016-10-24 | 126 | 0 |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016-10-21 | 137 | 0 |
| K161940 | Guidewire 0.6 Single Use | Fiagon GmbH | 2016-09-18 | 66 | 0 |
| K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc. | 2016-04-07 | 115 | 0 |
| K160479 | PointerShell Universal, PointerShell LS | Fiagon GmbH | 2016-03-23 | 30 | 0 |
| K160369 | GuideWire | Fiagon GmbH | 2016-03-10 | 29 | 0 |
| K153247 | Fusion Compact Navigation System | Medtronic Navigation, Inc. | 2016-02-18 | 101 | 0 |
| K150473 | FlexPointer 1.5 mm | Fiagon GmbH | 2015-04-16 | 52 | 0 |
| K141456 | THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTR | Fiagon GmbH | 2014-10-08 | 128 | 0 |
| K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFE | Stryker Corporate | 2014-09-08 | 89 | 1 |
| K133573 | FIAGON NAVIGATION SYSTEM | Fiagon GmbH | 2014-04-30 | 161 | 0 |
| K133665 | MALLEABLE SUCTION INSTRUMENTS | Medtronic Navigation, Inc. | 2014-03-13 | 104 | 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