510(k) · Cleared
ClearedRelieva and Relieva Acella Sinus Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · KAM Cannula, Sinus
Cleared on Mar 11, 2008 as substantially equivalent to K043527 (Exploramed Nc1, Inc., 2005) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 2005. 18 later devices descend from it.
- Decided
- Mar 11, 2008
- Review
- 134 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K043527 (2005). 18 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
- 1 generation backK061903 Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006
- This deviceK073041 Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK111875 Relieva Spin Sinus Dilation SystemAcclarent, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK090660 Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK120280 Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc. · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc. · 2011 · cites it directly7descendants
- K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011 · cites it directly7descendants
- K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · cites it directly4descendants
- K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015 · 2 generations on2descendants
- K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc. · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | 2005 | — |
| −1 | K061903 | Relieva Sinus Balloon Catheter | Acclarent, Inc. | 2006 | — |
| 0 (this device) | K073041 | Relieva and Relieva Acella Sinus Balloon Catheter | Acclarent, Inc. | 2008 | — |
| +1 | K111875 | Relieva Spin Sinus Dilation System | Acclarent, Inc. | 2011 | — |
| +1 | K111254 | Relieva Solo Elite Sinus Balloon Catheter | Acclarent, Inc. | 2011 | — |
| +1 | K090660 | Airway Balloon Catheter Inflation Device | Acclarent, Inc. | 2009 | 7 |
| +2 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015 | — |
| +2 | K120280 | Relieva Seeker Balloon Sinuplasty System | Acclarent, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 KAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K043527 | Relieva Sinus Balloon Dilation CatheterSummary page 1…4.4420 Classification Name: ENT Manual Surgical Instrument Product Code: ILRC Predicate Devices: Relieva Sinus Balloon Catheter (K043527) Relieva Acella Sinus Balloon Catheter (K061903) Device Description: The Relicva Sinus… | 2005 |
| * | K061903 | Relieva Sinus Balloon CatheterSummary page 1…Code: ILRC Predicate Devices: Relieva Sinus Balloon Catheter (K043527) Relieva Acella Sinus Balloon Catheter (K061903) Device Description: The Relicva Sinus Balloon Catheter is a catheter designed to dila… | 2006 |
What descends from it? (18)
See all 184 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 3 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111875 (Acclarent, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K043527.
How does its category compare?
All KAM devicesKAM Cannula, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KAM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KAM
Too few KAM 510(k)s in any year since 2007 to give a median.
Recalls per year · KAM
No recall names KAM since 2007.
Adverse event reports per year · KAM
3in 2016
MAUDE reports naming product code KAM, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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. Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within…
Read the full statement (105 words)
Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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.
Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073041: Relieva and Relieva Acella 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/K073041
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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