510(k) · Cleared
ClearedSINUSPRIME Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Ent · LRC Instrument, Ent Manual Surgical
Cleared on Oct 15, 2020 as substantially equivalent to K163509 (Entellus Medical, Inc., 2017) and 1 other predicate after a 140-day review. Its family tree reaches back 21 generations to 1994.
- Decided
- Oct 15, 2020
- Review
- 140 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K936109 (1994). 114 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 21 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 17 generations between
- 3 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 2 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 1 generation backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- This deviceK201398 SINUSPRIME Dilation SystemStryker Ent · 2020
Show all 21 generations
- Root · 21 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 20 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 19 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 18 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 17 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 16 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 15 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 14 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 13 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 12 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 11 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 10 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 9 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 8 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 7 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 6 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 5 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 4 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 3 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 2 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 1 generation backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- This deviceK201398 SINUSPRIME Dilation SystemStryker Ent · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −20 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −19 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −18 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −17 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −16 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −15 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −14 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −13 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −12 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −11 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −10 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −9 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −8 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −7 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −6 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −5 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −4 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −3 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| −2 | K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 | — |
| −1 | K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017 | — |
| 0 (this device) | K201398 | SINUSPRIME Dilation System | Stryker Ent | 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 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K163509 | XprESS ENT Dilation SystemSummary page 4…Class I, 21 CFR 874.4420 Class II 21 CFR 874.4180 Predicate Devices: K163509 XprESS ENT Dilation System K152435 LED Light Fiber Device Description: The SINU… | 2017 |
| * | K152435 | PassAssist LED Light FiberSummary page 4…Class II 21 CFR 874.4180 Predicate Devices: K163509 XprESS ENT Dilation System K152435 LED Light Fiber Device Description: The SINUSPRIME Dilation System is intended to remodel or recreate the sinus outflow tract a… | 2015 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 114 ancestors have a recall of any class.
- 4 other devices also cite its predicate K163509.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows: » Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostia/ethmoid infundibula in patients 2 years and older; » Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostia/recesses in patients 12 years and older; may be used with LED Light fiber to…
Read the full statement (126 words)
Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows:
» Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostia/ethmoid infundibula in patients 2 years and older;
» Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostia/recesses in patients 12 years and older; may be used with LED Light fiber to locate, illuminate within and, transilluminate across nasal and sinus structures;
» Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older;
» Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.
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/K201398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201398: SINUSPRIME Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201398
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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