510(k) · Cleared
ClearedRELIEVA ULTIRRA Sinus Balloon Catheter
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 May 3, 2019 as substantially equivalent to K111254 (Acclarent, Inc., 2011) after a 60-day review. Its family tree reaches back 15 generations to 1994.
- Decided
- May 3, 2019
- Review
- 60 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K936109 (1994). 81 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations between
- 3 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 2 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 1 generation backK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- This deviceK190525 RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc. · 2019
Show all 15 generations
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 14 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 13 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 12 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 11 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 10 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 9 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 6 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 5 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 4 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 3 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 2 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 1 generation backK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- This deviceK190525 RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −14 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −12 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −11 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −10 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −9 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −6 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −5 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −4 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −3 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −2 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −1 | K111254 | Relieva Solo Elite Sinus Balloon Catheter | Acclarent, Inc. | 2011 | — |
| 0 (this device) | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019 | — |
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 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K111254 | Relieva Solo Elite Sinus Balloon CatheterSummary page 4…Panel: Ear, Nose, and Throat Product Code: LRC [807.92(a)(3)] Legally Marketed Devices Predicate Device: RELIEVA Solo Elite™ Sinus Balloon Catheter (K111254) Reference Device: RELIEVA UltirraNav® Sinus Balloon Catheter, (K161698) [807.92(a)(4)] Device Description Device Descript… | 2011 |
| † | K161698 | Relieva UltirraNav Sinus Balloon Catheter | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 81 ancestors have a recall of any class.
- 4 other devices also cite its predicate K111254.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for…
Read the full statement (150 words)
The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.
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/K190525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190525: RELIEVA ULTIRRA Sinus Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190525
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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