510(k) · Cleared
ClearedEntellus Medical Balloon Device
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 Feb 5, 2010 as substantially equivalent to K081542 (Entellus Medical, Inc., 2008) and 1 other predicate after a 130-day review. Its family tree reaches back 12 generations to 1994. 41 later devices descend from it.
- Decided
- Feb 5, 2010
- Review
- 130 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K936109 (1994). 77 ancestors in all, the oldest K800617 (1980). 41 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 2 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 1 generation backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- This deviceK093007 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
- Descendant · 5 generations on · 14 of its ownK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 2 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 1 generation backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- This deviceK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- 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
- K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −2 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −1 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| 0 (this device) | 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 | — |
| +5 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K081542 | Modification to Entellus Medical RS-Series SystemSummary page 1…Class I Product Code LRC 1.2 SUBSTANTIAL EQUIVALENT PREDICATES The Entellus Medical is substantially equivalent to: K08 1542 - FinESS Sinus Treatment System K06 1903- Relieva Sinus Balloon Dilatation Catheter 5 10(k) exempt - Karl Storz F… | 2008 |
| * | K061903 | Relieva Sinus Balloon CatheterSummary page 1…LRC 1.2 SUBSTANTIAL EQUIVALENT PREDICATES The Entellus Medical is substantially equivalent to: K08 1542 - FinESS Sinus Treatment System K06 1903- Relieva Sinus Balloon Dilatation Catheter 5 10(k) exempt - Karl Storz Frontal Sinus Ostium Seeker 5 10(k) exempt… | 2006 |
| * | — | Karl Storz Frontal Sinus Ostium Seeker Named without a submission number | |
| * | — | Karl Storz Sphenoid Punch Named without a submission number | |
| * | — | 5F Ferguson or Frazier Suction Tube Named without a submission number |
What descends from it? (41)
See all 412 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 16 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 77 ancestors have a recall of any class.
- Of its descendants, K102003 (Entellus Medical, Inc., 2010) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K081542.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 frontal recesses and sphenoid sinus ostia in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093007: Entellus Medical Balloon Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093007
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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