510(k) · Cleared
ClearedVision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Aug 29, 2007 as substantially equivalent to K050972 (Vision-Sciences, Inc., 2005) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1992. 29 later devices descend from it.
- Decided
- Aug 29, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921244 (1992). 15 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 4 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 3 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 2 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 1 generation backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- This deviceK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK091829 PLS Portable Light SourceOptim, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- Descendant · 3 generations on · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008 · cites it directly15descendants
- K091829PLS Portable Light SourceOptim, Inc. · 2009 · 2 generations on9descendants
- K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · cites it directly7descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 3 generations on6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −4 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −3 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −2 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −1 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| 0 (this device) | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| +1 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| +2 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| +1 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| +3 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +4 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050972 | Vision-Sciences Ent-3000 ScopeSummary page 1…EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: K050972 / K040984 / K024095 / K942265 Device Description The VSI flexible endoscopes are flexible endoscopes with connections to a video… | 2005 |
| * | K040984 | Vision Sciences Model Ent-2000V Flexible Nasopharyngo-LaryngoscopeSummary page 1…EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: K050972 / K040984 / K024095 / K942265 Device Description The VSI flexible endoscopes are flexible endoscopes with connections to a video processor… | 2004 |
| * | K024095 | Modification to Vision Sciences Endosheath SystemSummary page 1…DA Regulations: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: K050972 / K040984 / K024095 / K942265 Device Description The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and displ… | 2003 |
| * | K942265 | Flexible Nasopharyngo-Laryngoscope and EndosheathSummary page 1…ions: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: K050972 / K040984 / K024095 / K942265 Device Description The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor… | 1995 |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | 2008 | 15 |
| K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences… | 2011 | 7 |
| K162916 | 3NT endoscopy system | 2017 | 3 |
| K150776 | Medrobotics Flex System | 2015 | 1 |
| K122134 | Flexlite Camera | 2012 | 0 |
| K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-V | 2009 | 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 15 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K080622 (Optim, Inc., 2008) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K050972.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
The digital video processor is intended for use with the VSI flexible video scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072073
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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