510(k) · Cleared
Recalled · Class II · 2024TruDi NAV Suction Instruments
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 Jul 20, 2018 as substantially equivalent to K161555 (Karl Storz Endoscopy America, Inc., 2016) and 1 other predicate after a 100-day review. Its family tree reaches back 5 generations to 1994. 3 of the 21 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times.
- Decided
- Jul 20, 2018
- Review
- 100 days
- Class
- Class II
- Product code
- PGW
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K911783 (1994). 20 ancestors in all, the oldest K871046 (1987). No later device cites it as a predicate yet. 3 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 3 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 2 generations backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- 1 generation backK161555 KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. · 2016
- This deviceK180948 TruDi NAV Suction InstrumentsAcclarent, Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −3 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −2 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| −1 | K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| 0 (this device) | K180948 | TruDi NAV Suction Instruments | Acclarent, Inc. | 2018 | — |
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 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K161555 | KARL STORZ NAV1 Electromagnetic Navigation SystemSummary page 4…iew Panel: Ear, Nose, and Throat Product Code: PGW [807.92(a)(3)] Legally Marketed Devices Predicate Device: KARL STORZ EM Navigated Suction Tubes, (K161555) (cleared as part of the KARL STORZ NAV1 Electromagnetic Navigation System under K161… | 2016 |
| * | K153555 | EM ENT Navigated SuctionsSummary page 4…cleared as part of the KARL STORZ NAV1 Electromagnetic Navigation System under K161555) Reference Device: Medtronic EM ENT Navigated Suctions, (K153555) [807.92(a)(4)] Device Description Device Description: TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically-… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2024 | Class II | Z-2507-2024 | Process control | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on… |
| Nov 12, 2021 | Class II | Z-0415-2022 | Process control | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead… |
| Mar 6, 2019 | Class II | Z-0824-2020 | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| Mar 6, 2019 | Class II | Z-0825-2020 | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| Mar 6, 2019 | Class II | Z-0826-2020 | Device Design | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
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 24 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K161555.
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. 2018, 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 Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments.
TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180948: TruDi NAV Suction Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180948
Report an extraction error
Are you the manufacturer?
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