510(k) · Cleared
ClearedPassAssist 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 Nov 20, 2015 as substantially equivalent to K141916 (Entellus Medical, Inc., 2014) after an 85-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Nov 20, 2015
- Review
- 85 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921244 (1992). 26 ancestors in all, the oldest K864821 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations between
- 3 generations backK091829 PLS Portable Light SourceOptim, Inc. · 2009
- 2 generations backK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- 1 generation backK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- This deviceK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK230258 BB 8 Sinus Dilation KitExcelent, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK201398 SINUSPRIME Dilation SystemStryker Ent · 2020
Show all 10 generations
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 9 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 8 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 7 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 6 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 5 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 4 generations backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- 3 generations backK091829 PLS Portable Light SourceOptim, Inc. · 2009
- 2 generations backK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- 1 generation backK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- This deviceK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −9 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −8 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −7 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −6 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −5 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| −4 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| −3 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| −2 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| −1 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| 0 (this device) | K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 | — |
| +1 | K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023 | — |
| +1 | K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K141916 | Pathassist Led Light FiberSummary page 4…LRC Regulation Number: Class I, 21 CFR 874.4420 Predicate Device: PathAssist LED Light Fiber [K141916] Device Description: The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light… | 2014 |
What descends from it? (2)
2 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 23 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K230258 (Excelent, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141916.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152435: PassAssist 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/K152435
Report an extraction error
Are you the manufacturer?
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