510(k) · Cleared
ClearedEM Sinus Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · LRC Instrument, Ent Manual Surgical
Cleared on Nov 5, 2013 as substantially equivalent to K121351 (Entrigue Surgical, Inc., 2012) and 1 other predicate after a 104-day review. Its family tree reaches back 15 generations to 1994. 5 later devices descend from it.
- Decided
- Nov 5, 2013
- Review
- 104 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K936109 (1994). 80 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 3 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 backK121351 Sinus Dilation SystemEntrigue Surgical, Inc. · 2012
- This deviceK132297 EM Sinus Dilation SystemMedtronic Xomed, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK201472 VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020
- Descendant · cites it directly · 1 of its ownK161698 Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK172737 MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited · 2017
- Descendant · cites it directly · 0 of its ownK152121 NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc. · 2015
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 backK121351 Sinus Dilation SystemEntrigue Surgical, Inc. · 2012
- This deviceK132297 EM Sinus Dilation SystemMedtronic Xomed, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020 · cites it directly1descendant
- K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. · 2016 · cites it directly1descendant
- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · 2 generations on0descendants
- K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited · 2017 · 2 generations on0descendants
- K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc. · 2015 · cites it directly0descendants
View 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 | K121351 | Sinus Dilation System | Entrigue Surgical, Inc. | 2012 | — |
| 0 (this device) | K132297 | EM Sinus Dilation System | Medtronic Xomed, Inc. | 2013 | — |
| +1 | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020 | — |
| +1 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016 | — |
| +2 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
| +2 | K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017 | — |
| +1 | K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K121351 | Sinus Dilation SystemSummary page 2…y equivalent in-intended use and performance characteristics to the follow predicate devices: ' Description $10(k) Number Clearance Date ENTrigue Sinus Dilation System | K121351 - 08/29720]3 XprESS Multi-Sinus Dilation Tool | K102003 10/22/2010 The table comparing the proposed and predicate devices is pre… | 2012 |
| * | K102003 | Xpress Balloon DeviceSummary page 2…tics to the follow predicate devices: ' Description $10(k) Number Clearance Date ENTrigue Sinus Dilation System | K121351 - 08/29720]3 XprESS Multi-Sinus Dilation Tool | K102003 10/22/2010 The table comparing the proposed and predicate devices is presented on the next page. 1X. Comparison… | 2010 |
| † | K093007 | Entellus Medical Balloon Device | 2010 |
| † | K081542 | Modification to Entellus Medical RS-Series System | 2008 |
What descends from it? (5)
3 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 19 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 80 ancestors have a recall of any class.
- Of its descendants, K201472 (Fiagon GmbH, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K121351.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses. The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system. The Medtronic computer-assisted surgery system and its associated applications…
Read the full statement (153 words)
The EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses.
The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system.
The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.
The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132297: EM Sinus Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132297
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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