510(k) · Cleared
ClearedVenSure Balloon Device, VenSure Nav Balloon Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiagon GmbH · LRC Instrument, Ent Manual Surgical
Cleared on Aug 26, 2020 as substantially equivalent to K142252 (Entellus Medical, Inc., 2014) and 1 other predicate after an 84-day review. Its family tree reaches back 19 generations to 1994. 1 later device descends from it.
- Decided
- Aug 26, 2020
- Review
- 84 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K936109 (1994). 86 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 15 generations between
- 3 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 2 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 1 generation backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- This deviceK201472 VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020
- Descendant · cites it directly · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
Show all 19 generations
- Root · 19 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 18 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 17 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 16 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 15 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 14 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 13 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 12 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 11 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 10 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 9 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 8 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 7 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 6 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 5 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 4 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 3 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 2 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 1 generation backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- This deviceK201472 VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020
Most influential descendants
Showing 1 of 1 · See all- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −18 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −17 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −16 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −15 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −14 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −13 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −12 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −11 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −10 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −9 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −8 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −7 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −6 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −5 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −4 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −3 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −2 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −1 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| 0 (this device) | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020 | — |
| +1 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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.
Planning a device in LRC? 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 LRC device
- #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 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 |
|---|---|---|---|
| * | K142252 | XprESS Multi-Sinus Dilation ToolSummary page 4…alloon Device and VenSureTM Nav Balloon Device are substantially equivalent to the following predicate devices: • Primary predicate: XprESS Multi-Sinus Dilation Tool (K142252) • Secondary predicate: Medtronic EM Sinus Dilation System (K132297) 4. Device Description Fiagon’s VenSure™ Balloon Device… | 2014 |
| * | K132297 | EM Sinus Dilation SystemSummary page 4…nt to the following predicate devices: • Primary predicate: XprESS Multi-Sinus Dilation Tool (K142252) • Secondary predicate: Medtronic EM Sinus Dilation System (K132297) 4. Device Description Fiagon’s VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, single- use devices designe… | 2013 |
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 |
|---|---|---|---|
| K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav… | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 86 ancestors have a recall of any class.
- Of its descendants, K230065 (Fiagon GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142252.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LRC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LRC
131in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRC
44in 2025
MAUDE reports naming product code LRC, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 2 | — | 0 | 11 |
| 2011 | 6 | 106 | 0 | 14 |
| 2012 | 7 | 50 | 0 | 48 |
| 2013 | 7 | 104 | 0 | 53 |
| 2014 | 3 | 29 | 0 | 53 |
| 2015 | 6 | 105 | 0 | 41 |
| 2016 | 3 | 100 | 0 | 39 |
| 2017 | 2 | — | 0 | 32 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 4 | 131 | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 25 |
| 2023 | 1 | — | 1 | 14 |
| 2024 | 0 | — | 1 | 51 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon Navigation System during sinus procedures when…
Read the full statement (170 words)
The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon Navigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201472: VenSure Balloon Device, VenSure Nav Balloon Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201472
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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