510(k) · Cleared
ClearedRelieva Scout Multi-Sinus Dilation 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 Feb 12, 2016 as substantially equivalent to K120280 (Acclarent, Inc., 2012) and 2 other predicates after an 85-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Feb 12, 2016
- Review
- 85 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K936109 (1994). 85 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- 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 backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 1 generation backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- This deviceK153341 Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. · 2016
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 backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 1 generation backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- This deviceK153341 Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. · 2016
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 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −1 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| 0 (this device) | K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016 | — |
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 |
| 2012 | 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 |
|---|---|---|---|
| * | K120280 | Relieva Seeker Balloon Sinuplasty SystemSummary page 4…al Instrument (21 CFR 874.4420) Product Code: LRC [807.92(a)(3)] Legally Marketed Devices Predicate Devices: RELIEVA SCOUT® Sinus Dilation System (K120280) XprESS™ Multi-Sinus Dilation Tool (K121174) RELIEVA® Spin Balloon Sinuplasty… | 2012 |
| * | K121174 | Xpress Multi-Sinus Dilation ToolSummary page 4…92(a)(3)] Legally Marketed Devices Predicate Devices: RELIEVA SCOUT® Sinus Dilation System (K120280) XprESS™ Multi-Sinus Dilation Tool (K121174) RELIEVA® Spin Balloon Sinuplasty System (K111875) [807.92(a)(4)] Device Description Device Descrip… | 2012 |
| * | K111875 | Relieva Spin Sinus Dilation SystemSummary page 4…Sinus Dilation System (K120280) XprESS™ Multi-Sinus Dilation Tool (K121174) RELIEVA® Spin Balloon Sinuplasty System (K111875) [807.92(a)(4)] Device Description Device Description: The Relieva Scout™ Multi-Sinus Dilation System is a sterile, sing… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 85 ancestors have a recall of any class.
- 1 other device also cites its predicate K120280.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153341: Relieva Scout Multi-Sinus Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153341
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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