510(k) · Cleared
ClearedTruDi NAV Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on May 3, 2019 as substantially equivalent to K161697 (Acclarent, Inc., 2016) after a 60-day review. Its family tree reaches back 6 generations to 1994. 3 of the 18 devices in its family, counting itself, have a Class I recall.
- Decided
- May 3, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K911783 (1994). 17 ancestors in all, the oldest K871046 (1987). No later device cites it as a predicate yet. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 4 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 3 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 2 generations backK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- 1 generation backK161697 Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016
- This deviceK190532 TruDi NAV WireAcclarent, Inc. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −5 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −4 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −3 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −2 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| −1 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016 | — |
| 0 (this device) | K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 1 |
| 1998 | 2 | 2 |
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGW device
- #1 K261540 Cube 4D Navigation System, VirtuEye Proscore 12.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161697 | Acclarent NavWire Sinus Navigation GuidewireSummary page 4…Ear, Nose, and Throat Product Code: PGW [807.92(a)(3)] Legally Marketed Devices Predicate Device: Acclarent® NavWire Sinus Navigation Guidewire, (K161697) Reference Device: Relieva SpinPlus® Nav Balloon Sinuplasty System, (K171687) [807.92(a)(4)] Device Description Device… | 2016 |
| † | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 17 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K161697.
How does its category compare?
All PGW devicesPGW Ear, Nose, And Throat Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PGW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGW
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGW
220in 2025
MAUDE reports naming product code PGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 4 | 116 | 0 | 7 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 9 | 115 | 0 | 33 |
| 2017 | 4 | 125 | 0 | 42 |
| 2018 | 2 | — | 0 | 96 |
| 2019 | 1 | — | 3 | 247 |
| 2020 | 8 | 100 | 0 | 161 |
| 2021 | 1 | — | 1 | 190 |
| 2022 | 2 | — | 0 | 166 |
| 2023 | 2 | — | 1 | 200 |
| 2024 | 0 | — | 0 | 274 |
| 2025 | 1 | — | 1 | 220 |
| 2026 | 3 | 65 | 0 | — |
What is it indicated for?
TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation
of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid
anatomical structure can be identified relative to a CT-based model of the anatomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190532 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190532: TruDi NAV Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190532
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026