510(k) · Cleared
ClearedCARTO ENT 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 Oct 24, 2016 as substantially equivalent to K133573 (Fiagon GmbH, 2014) after a 126-day review. Its family tree reaches back 4 generations to 1994. 3 of the 17 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Oct 24, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- PGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911783 (1994). 13 ancestors in all, the oldest K871046 (1987). 3 later devices descend from it, 1 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 3 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 2 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 1 generation backK133573 Fiagon Navigation SystemFiagon GmbH · 2014
- This deviceK161701 CARTO ENT SystemBiosense Webster · 2016
- Descendant · cites it directly · 2 of its ownK173628 Acclarent ENT Navigation SystemAcclarent, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK192397 TruDi Navigation SystemBiosense Webster · 2020 · Recalled
- Descendant · 3 generations on · 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −3 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −2 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −1 | K133573 | Fiagon Navigation System | Fiagon GmbH | 2014 | — |
| 0 (this device) | K161701 | CARTO ENT System | Biosense Webster | 2016 | — |
| +1 | K173628 | Acclarent ENT Navigation System | Acclarent, Inc. | 2018 | — |
| +2 | K192397 | TruDi Navigation System | Biosense Webster | 2020 | 1 |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K133573 | Fiagon Navigation SystemSummary page 4…Manual Surgical Instrument (21 CFR 882.4560) Name: Product Code: PGW [807.92(a)(3)] Legally Marketed Devices Predicate Devices: Fiagon Navigation System (K133573) Reference Devices: CARTO 3 EP Navigation System (K133916) [807.92(a)(4)] Device Description The CA… | 2014 |
| † | K133916 | Carto 3 EP Navigation System, Version 4.2 | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173628 | Acclarent ENT Navigation System | 2018 | 2 |
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.
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 13 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K173628 (Acclarent, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K133573.
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. 2016, 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 CARTO® ENT System is intended for use during intranasal and paranasal image-guided navigation procedures for
patients who are cligible for sinus procedures.
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/K161701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161701: CARTO ENT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161701
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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