510(k) · Cleared
ClearedRelieva Sinus Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exploramed Nc1, Inc. · LRC Instrument, Ent Manual Surgical
Cleared on Apr 5, 2005 after a 105-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 55 later devices descend from it.
- Decided
- Apr 5, 2005
- Review
- 105 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
55 later devices descend from it, 4 citing it directly.
- This deviceK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
- Descendant · cites it directly · 49 of its ownK061903 Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006
- Descendant · cites it directly · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 2 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 2 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 3 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K061903Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006 · cites it directly49descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · cites it directly44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 2 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | 2005 | — |
| +1 | K061903 | Relieva Sinus Balloon Catheter | Acclarent, Inc. | 2006 | — |
| +1 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +2 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +2 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +3 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K935233 | FDA’s K935233 is Iolab Lacrimal Duct Catheter Our reading of the summary gave K935233, FDA’s number for Iolab Lacrimal Duct Catheter (Chiron Vision Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lacricath”. Kept off the family tree. Summary page 2…xlrae C1Endoscopy America Endoscopy America 510(k) Number K043527 Pre-Amendments Pre-Amendments K935233 CFR Section 874.4420 874,4420 874.4420 886.4350 Device Classification Product Co… | 1994 |
| * | — | Circular Cutting Punch Named without a submission number | |
| * | — | Antrum Curette Named without a submission number |
What descends from it? (55)
See all 554 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?
- Of its descendants, K061903 (Acclarent, Inc., 2006) has gone furthest, with 49 descendants of its own.
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?
The Relieva Sinus Balloon Dilation Catheter is intended to provide a means 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/K043527 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043527: Relieva Sinus Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043527
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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