510(k) · Cleared
ClearedPathassist Led 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 Jun 11, 2013 as substantially equivalent to K120962 (Entellus Medical, Inc., 2012) and 1 other predicate after a 104-day review. Its family tree reaches back 8 generations to 1992. 6 later devices descend from it.
- Decided
- Jun 11, 2013
- Review
- 104 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921244 (1992). 24 ancestors in all, the oldest K864821 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 7 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 6 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 5 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 4 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 3 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 2 generations backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- 1 generation backK091829 PLS Portable Light SourceOptim, Inc. · 2009
- This deviceK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK212774 VenSure LightGuideIntersect Ent. · 2022
- Descendant · 3 generations on · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK230258 BB 8 Sinus Dilation KitExcelent, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · cites it directly5descendants
- K152435PassAssist LED Light FiberEntellus Medical, Inc. · 2015 · 2 generations on2descendants
- K212774VenSure LightGuideIntersect Ent. · 2022 · 2 generations on1descendant
- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · 3 generations on0descendants
- K230258BB 8 Sinus Dilation KitExcelent, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −7 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −6 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −5 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −4 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −3 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| −2 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| −1 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| 0 (this device) | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +1 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +2 | K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 | — |
| +2 | K212774 | VenSure LightGuide | Intersect Ent. | 2022 | — |
| +3 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
| +3 | K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K120962 | Pathassist Light FiberSummary page 1…-7066 [email protected] PathAssist LED Light Fiber " Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC PathAssist Light Fiber [K120962] “PLS” Portable Light Source [K091829] Device Description: The PathAssist LED Light Fiber is a flexible instrument that emits li… | 2012 |
| * | K091829 | PLS Portable Light SourceSummary page 1…athAssist LED Light Fiber " Sinus Guidewire 21 CFR 874.4420 ENT Manual Surgical Instrument ENT Class I LRC PathAssist Light Fiber [K120962] “PLS” Portable Light Source [K091829] Device Description: The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Ligh… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141916 | Pathassist Led Light Fiber | 2014 | 5 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K141916 (Entellus Medical, Inc., 2014) has gone furthest, with 5 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. 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?
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients
aged 18 and over.
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/K130503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130503: Pathassist Led Light Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130503
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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