510(k) · Cleared
ClearedRelieva SpinPlus Balloon Sinuplasty System
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 Apr 22, 2015 as substantially equivalent to K111875 (Acclarent, Inc., 2011) and 2 other predicates after a 128-day review. Its family tree reaches back 15 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 22, 2015
- Review
- 128 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K936109 (1994). 83 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK171687 Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK201115 Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
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 deviceK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView 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) | K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015 | — |
| +1 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017 | — |
| +1 | K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020 | — |
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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111875 | Relieva Spin Sinus Dilation SystemSummary page 4…Ear, Nose, and Throat Manual Surgical Instrument Product Code: LRC Predicate Devices: Relieva Spin Sinus Dilation System (Primary Predicate, K111875) Relieva Solo Elite Sinus Balloon Catheter (K111254) Relieva Luma Sinus Ill… | 2011 |
| * | K111254 | Relieva Solo Elite Sinus Balloon CatheterSummary page 4…LRC Predicate Devices: Relieva Spin Sinus Dilation System (Primary Predicate, K111875) Relieva Solo Elite Sinus Balloon Catheter (K111254) Relieva Luma Sinus Illumination System (K071845) Device Description: The Relieva SpinPlus Bal… | 2011 |
| * | K071845 | Relieva Luma Sinus Illumination System, Model Sis-100ASummary page 4…ary Predicate, K111875) Relieva Solo Elite Sinus Balloon Catheter (K111254) Relieva Luma Sinus Illumination System (K071845) Device Description: The Relieva SpinPlus Balloon Sinuplasty System is an integrated device th… | 2007 |
What descends from it? (2)
2 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 21 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 83 ancestors have a recall of any class.
- Of its descendants, K171687 (Acclarent, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K111875.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the Relieva…
Read the full statement (122 words)
The Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
For children aged 17 and under, the Relieva SpinPlus Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; and irrigate from within the maxillary sinus for therapeutic procedures and to facilitate diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143541: Relieva SpinPlus Balloon Sinuplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143541
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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