510(k) · Cleared
ClearedRelieva SpinPlus Nav 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 Sep 5, 2017 as substantially equivalent to K143541 (Acclarent, Inc., 2015) and 1 other predicate after a 90-day review. Its family tree reaches back 16 generations to 1994. 3 of the 103 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 5, 2017
- Review
- 90 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K936109 (1994). 101 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly. 3 of the 103 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations between
- 3 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 2 generations backK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- 1 generation backK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
- This deviceK171687 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 16 generations
- Root · 16 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 15 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 14 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 13 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 12 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 11 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 10 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 9 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 7 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 6 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 5 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 4 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 3 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 2 generations backK111254 Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc. · 2011
- 1 generation backK143541 Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc. · 2015
- This deviceK171687 Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K201115Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −15 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −13 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −12 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −11 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −10 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −9 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −7 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −6 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −5 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −4 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −3 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −2 | K111254 | Relieva Solo Elite Sinus Balloon Catheter | Acclarent, Inc. | 2011 | — |
| −1 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015 | — |
| 0 (this device) | 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 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 1 |
| 1997 | 5 | 0 |
| 1998 | 9 | 2 |
| 1999 | 1 | 0 |
| 2000 | 13 | 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 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K143541 | Relieva SpinPlus Balloon Sinuplasty SystemSummary page 4…ment (21 CFR 874.4420) Product Code: LRC [807.92(a)(3)] Legally Marketed Devices Predicate Devices: RELIEVA SPINPLUS® Balloon Sinuplasty System, (K143541) ACCLARENT® NAVWIRE™ Sinus Navigation System, (K161697) Reference Devices… | 2015 |
| * | K161697 | Acclarent NavWire Sinus Navigation GuidewireSummary page 4…eted Devices Predicate Devices: RELIEVA SPINPLUS® Balloon Sinuplasty System, (K143541) ACCLARENT® NAVWIRE™ Sinus Navigation System, (K161697) Reference Devices Medtronic NuVent™ EM Sinus Dilation System, (K152121) [807.92(a)(4)] Device De… | 2016 |
| † | K152121 | NuVent EM Sinus Dilation System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201115 | Next Generation Balloon Dilation System | 2020 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 101 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K201115 (Acclarent, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143541.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space within and 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 Nav™ Balloon…
Read the full statement (152 words)
The Relieva SpinPlus Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space within and 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 Nav™ Balloon Sinuplasty System is intended to provide a means to access the sinus space, within and 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.
The Relieva SpinPlus Nav™ Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171687: Relieva SpinPlus Nav Balloon Sinuplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171687
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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