510(k) · Cleared
ClearedRelieva Solo Elite 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 Aug 22, 2011 as substantially equivalent to K073041 (Acclarent, Inc., 2008) and 1 other predicate after a 110-day review. Its family tree reaches back 14 generations to 1994. 7 later devices descend from it.
- Decided
- Aug 22, 2011
- Review
- 110 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K936109 (1994). 80 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations between
- 3 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 2 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 1 generation backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- This deviceK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK171687 Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK161698 Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK201115 Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190525 RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc. · 2019
Show all 14 generations
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 13 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 12 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 11 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 10 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 9 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 8 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 5 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 4 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 3 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 2 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 1 generation backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- This deviceK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015 · cites it directly2descendants
- K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. · 2017 · 2 generations on1descendant
- K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. · 2016 · cites it directly1descendant
- K201115Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020 · 2 generations on0descendants
- K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −13 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −11 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −10 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −9 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −8 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −5 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −4 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −3 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −2 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −1 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| 0 (this device) | K111254 | Relieva Solo Elite Sinus Balloon Catheter | Acclarent, Inc. | 2011 | — |
| +1 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015 | — |
| +2 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017 | — |
| +1 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016 | — |
| +2 | K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K073041 | Relieva and Relieva Acella Sinus Balloon CatheterSummary page 1…4.4420 Classification Name: Ear, nose, and throat manual surgical instrument Product Code: LRC Predicate Devices: Relieva Sinus Balloon Catheter (K073041) Xpress Multi-Sinus Dilation Tool (K102003) Device Description: The Relieva Solo Elite Sinus Ballo… | 2008 |
| * | K102003 | Xpress Balloon DeviceSummary page 1…al instrument Product Code: LRC Predicate Devices: Relieva Sinus Balloon Catheter (K073041) Xpress Multi-Sinus Dilation Tool (K102003) Device Description: The Relieva Solo Elite Sinus Balloon Catheter is a flexible catheter that is… | 2010 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 80 ancestors have a recall of any class.
- Of its descendants, K143541 (Acclarent, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K073041.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Solo Elite 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 Relieva Solo Elite Sinus Balloon Catheter 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111254: Relieva Solo Elite 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/K111254
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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