510(k) · Cleared
Recalled · 2011Vision-Sciences Ent-3000 Scope
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 Apr 29, 2005 as substantially equivalent to K942265 (Vision-Sciences, Inc., 1995) and 1 other predicate after an 11-day review. Its family tree reaches back 3 generations to 1992. 30 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921244 (1992). 7 ancestors in all. 30 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 2 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 1 generation backK990354 EndosheathVision-Sciences, Inc. · 1999
- This deviceK050972 Vision-Sciences Ent-3000 ScopeVision-Sciences, Inc. · 2005
- Descendant · cites it directly · 29 of its ownK072073 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 · 2 generations on · 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K072073Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Vision-Sciences, Inc. · 2007 · cites it directly29descendants
- 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 · 2 generations on7descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −2 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −1 | K990354 | Endosheath | Vision-Sciences, Inc. | 1999 | — |
| 0 (this device) | K050972 | Vision-Sciences Ent-3000 Scope | Vision-Sciences, Inc. | 2005 | — |
| +1 | 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 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 510(k) statement (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? (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 |
|---|---|---|---|
| * | K942265 | Flexible Nasopharyngo-Laryngoscope and EndosheathSummary page 1…According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K942265 - Flexible ENT Scope K990354 - Modified EndoSheath® for Flexible ENT Scopes Man… | 1995 |
| * | K990354 | EndosheathSummary page 1…, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K942265 - Flexible ENT Scope K990354 - Modified EndoSheath® for Flexible ENT Scopes Manufactured by: Vision-Sciences… | 1999 |
What descends from it? (30)
See all 303 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2011 | Not classified | Z-0928-2012 | Nonconforming Material/Component | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. |
| Dec 27, 2011 | Not classified | Z-0929-2012 | Nonconforming Material/Component | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K072073 (Vision-Sciences, Inc., 2007) has gone furthest, with 29 descendants of its own.
- 3 other devices also cite its predicate K942265.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 VSI Flexible ENT Scope is intended for flexible endoscopic examination
of the upper airway, vocal chords and/or nasal passages.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050972: Vision-Sciences Ent-3000 Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050972
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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