510(k) · Cleared
ClearedModification to Entellus Medical RS-Series System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entellus Medical, Inc. · LRC Instrument, Ent Manual Surgical
Cleared on Jun 27, 2008 as substantially equivalent to K072302 (Entellus Medical, Inc., 2008) after a 25-day review. Its family tree reaches back 11 generations to 1994. 42 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 25 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K936109 (1994). 75 ancestors in all, the oldest K800617 (1980). 42 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations between
- 3 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 2 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 1 generation backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- This deviceK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · cites it directly · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · cites it directly · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 2 generations on · 21 of its ownK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- Descendant · 3 generations on · 20 of its ownK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- Descendant · 4 generations on · 17 of its ownK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
Show all 11 generations
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 9 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 8 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 7 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 6 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 5 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 3 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 2 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 1 generation backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- This deviceK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · cites it directly41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · cites it directly36descendants
- K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011 · 2 generations on21descendants
- K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012 · 3 generations on20descendants
- K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −10 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −8 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −7 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −6 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −5 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −3 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −2 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −1 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| 0 (this device) | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +1 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +1 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +2 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| +3 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| +4 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K072302 | Entellus Medical RS-Series SystemSummary page 2…using saline. 12.4 SUBSTANTIAL EQUIVALENCE The Entellus Medical FinESS Sinus Treatment is substantially equivalent to the previously cleared device (K072302). The Entellus Medical FinESS Sinus Treatment (FinESS) has the same Intended Use as its predicate. Like its predic… | 2008 |
What descends from it? (42)
See all 422 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 14 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 75 ancestors have a recall of any class.
- Of its descendants, K093007 (Entellus Medical, Inc., 2010) has gone furthest, with 41 descendants of its own.
- 1 other device also cites its predicate K072302.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081542: Modification to Entellus Medical RS-Series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081542
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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