510(k) · Cleared
ClearedNext Generation Balloon Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · LRC Instrument, Ent Manual Surgical
Cleared on Aug 27, 2020 as substantially equivalent to K171761 (Acclarent, Inc., 2018) and 2 other predicates after a 122-day review. Its family tree reaches back 22 generations to 1994. 3 of the 112 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 27, 2020
- Review
- 122 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K936109 (1994). 111 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet. 3 of the 112 devices in this family, counting this one, have a Class I recall.
- Root · 22 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 18 generations between
- 3 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 2 generations backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- 1 generation backK171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018
- This deviceK201115 Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
Show all 22 generations
- Root · 22 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 21 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 20 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 19 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 18 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 17 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 16 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 15 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 14 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 13 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 12 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 11 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 10 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 9 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 8 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 7 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 6 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 5 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 4 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 3 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 2 generations backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- 1 generation backK171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018
- This deviceK201115 Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −21 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −20 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −19 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −18 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −17 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −16 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −15 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −14 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −13 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −12 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −11 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −10 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −9 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −8 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −7 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −6 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −5 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −4 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| −3 | K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 | — |
| −2 | K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017 | — |
| −1 | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018 | — |
| 0 (this device) | K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 1 |
| 1997 | 5 | 0 |
| 1998 | 9 | 2 |
| 1999 | 1 | 0 |
| 2000 | 13 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 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? (3)
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 |
|---|---|---|---|
| * | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation SystemSummary page 4…rketed Devices ® Primary Predicate Device: Acclarent AERA Eustachian Tube Balloon Dilation System (K171761) Secondary Predicate Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687) Devices: Relie… | 2018 |
| * | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemSummary page 4…arent AERA Eustachian Tube Balloon Dilation System (K171761) Secondary Predicate Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687) Devices: Relieva SpinPlus® Balloon Sinuplasty System (K143541) Reference Device: Acclarent… | 2017 |
| * | K143541 | Relieva SpinPlus Balloon Sinuplasty SystemSummary page 4…) Secondary Predicate Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687) Devices: Relieva SpinPlus® Balloon Sinuplasty System (K143541) Reference Device: Acclarent TruDi NAV Wire (K190532) Next Generation Balloon Dilation System… | 2015 |
| † | K190532 | TruDi NAV Wire | 2019 |
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 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 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 8 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 111 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K171761.
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 NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the NGB Balloon Dilation System is intended to…
Read the full statement (221 words)
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures.
The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube.
The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.
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/K201115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201115: Next Generation Balloon Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201115
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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