510(k) · Cleared
Recalled · Class II · 2023TruDi Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster · PGW Ear, Nose, And Throat Stereotaxic Instrument
Cleared on Jan 30, 2020 as substantially equivalent to K173628 (Acclarent, Inc., 2018) and 1 other predicate after a 149-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. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 30, 2020
- Review
- 149 days
- Class
- Class II
- Product code
- PGW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911783 (1994). 16 ancestors in all, the oldest K871046 (1987). 1 later device descends from it, 1 citing it directly. 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 backK161701 CARTO ENT SystemBiosense Webster · 2016
- 1 generation backK173628 Acclarent ENT Navigation SystemAcclarent, Inc. · 2018
- This deviceK192397 TruDi Navigation SystemBiosense Webster · 2020
- Descendant · cites it directly · 0 of its ownK231862 TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc. · 2023 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc. · 2023 · cites it directly0descendants
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 | K161701 | CARTO ENT System | Biosense Webster | 2016 | — |
| −1 | K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018 | — |
| 0 (this device) | K192397 | TruDi Navigation System | Biosense Webster | 2020 | — |
| +1 | K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023 | 1 |
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 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K173628 | Acclarent ENT Navigation SystemSummary page 4…882.4560) Product Code PGW [807.92(a)(3)] Legally Marketed Devices Predicate Devices: Primary: Acclarent® ENT Navigation System (K173628) Secondary: Fiagon Navigation System (K162176) [807.92(a)(4)] Device Description Device… | 2018 |
| * | K162176 | Fiagon Navigation SystemSummary page 4…Marketed Devices Predicate Devices: Primary: Acclarent® ENT Navigation System (K173628) Secondary: Fiagon Navigation System (K162176) [807.92(a)(4)] Device Description Device The TruDi™ Navigation System V2 is intended to be used during… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | 2023 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2023 | Class II | Z-0127-2024 | Software Design Change | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT… |
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.
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K231862 (Acclarent, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
The TruDi™ Navigation System is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to rigid anatomic structure can be identified relative to a CT or MR based model.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192397: TruDi Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192397
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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