510(k) · Cleared
ClearedPathassist Light Fiber
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 Apr 27, 2012 as substantially equivalent to K111763 (Entellus Medical, Inc., 2011) after a 28-day review. Its family tree reaches back 2 generations to 2007. 7 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 28 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071845 (2007). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK071845 Relieva Luma Sinus Illumination System, Model Sis-100AAcclarent, Inc. · 2007
- 1 generation backK111763 Pathassist Light FiberEntellus Medical, Inc. · 2011
- This deviceK120962 Pathassist Light FiberEntellus Medical, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK212774 VenSure LightGuideIntersect Ent. · 2022
- Descendant · 4 generations on · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · cites it directly6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 2 generations on5descendants
- K152435PassAssist LED Light FiberEntellus Medical, Inc. · 2015 · 3 generations on2descendants
- K212774VenSure LightGuideIntersect Ent. · 2022 · 3 generations on1descendant
- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071845 | Relieva Luma Sinus Illumination System, Model Sis-100A | Acclarent, Inc. | 2007 | — |
| −1 | K111763 | Pathassist Light Fiber | Entellus Medical, Inc. | 2011 | — |
| 0 (this device) | K120962 | Pathassist Light Fiber | Entellus Medical, Inc. | 2012 | — |
| +1 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +2 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +3 | K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 | — |
| +3 | K212774 | VenSure LightGuide | Intersect Ent. | 2022 | — |
| +4 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K111763 | Pathassist Light Fiber | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130503 | Pathassist Led Light Fiber | 2013 | 6 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130503 (Entellus Medical, Inc., 2013) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120962 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120962: Pathassist Light Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120962
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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