510(k) · Cleared
ClearedRelieva 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 18, 2006 as substantially equivalent to K043527 (Exploramed Nc1, Inc., 2005) after a 44-day review. Its family tree reaches back 1 generation to 2005. 49 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 44 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K043527 (2005). 49 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
- This deviceK061903 Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006
- Descendant · cites it directly · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 2 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 3 generations on · 21 of its ownK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- Descendant · 4 generations on · 20 of its ownK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK073041 Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · cites it directly41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 2 generations on36descendants
- K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011 · 3 generations on21descendants
- K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012 · 4 generations on20descendants
- K073041Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | 2005 | — |
| 0 (this device) | K061903 | Relieva Sinus Balloon Catheter | Acclarent, Inc. | 2006 | — |
| +1 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +2 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +3 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| +4 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| +1 | K073041 | Relieva and Relieva Acella Sinus Balloon Catheter | Acclarent, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043527 | Relieva Sinus Balloon Dilation CatheterSummary page 1…21 CFR 874.4420 Classification Name: ENT Manual Surgical Instrument Product Code: LRC Predicate Device: Relieva Sinus Balloon Catheter (K043527) Relieva Sinus Guidewire (K043445) Device Description: The Sinus Balloon Catheter-Integrated Wire… | 2005 |
| Kept off the family tree | K043445 | Relieva Sinus Guidewire Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Surgical Instrument Product Code: LRC Predicate Device: Relieva Sinus Balloon Catheter (K043527) Relieva Sinus Guidewire (K043445) Device Description: The Sinus Balloon Catheter-Integrated Wire is a sinus balloon catheter that… |
What descends from it? (49)
See all 493 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?
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061903: Relieva Sinus Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061903
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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