510(k) · Cleared
ClearedVenSure LightGuide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersect Ent. · LRC Instrument, Ent Manual Surgical
Cleared on Feb 4, 2022 as substantially equivalent to K141916 (Entellus Medical, Inc., 2014) after a 156-day review. Its family tree reaches back 10 generations to 1992. 1 later device descends from it.
- Decided
- Feb 4, 2022
- Review
- 156 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). 1 later device descends from it, 1 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 deviceK212774 VenSure LightGuideIntersect Ent. · 2022
- Descendant · cites it directly · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
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 deviceK212774 VenSure LightGuideIntersect Ent. · 2022
Most influential descendants
Showing 1 of 1 · See all- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · cites it directly0descendants
View 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) | K212774 | VenSure LightGuide | Intersect Ent. | 2022 | — |
| +1 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 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 |
|---|---|---|
| 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…manual surgical instrument Product Code: LRC 3.Predicate Device Information The VenSureTM LightGuide is substantially equivalent to PathAssist LED Light Fiber (K141916). 4.Device Description VenSureTM LightGuide is a sterile, single-use device designed to emit light from the distal end. The dev… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav… | 2023 | 0 |
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 30 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K230065 (Fiagon GmbH, 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. 2022, 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 VenSureTM LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212774: VenSure LightGuide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212774
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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