510(k) · Cleared
ClearedEntity Nasoview Led Nasopharyngoscope, Model 006105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optim, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Apr 2, 2008 as substantially equivalent to K864821 (Reichert-Jung, Inc., 1987) and 3 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1992. 15 later devices descend from it.
- Decided
- Apr 2, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K921244 (1992). 17 ancestors in all, the oldest K864821 (1987). 15 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 1 generation backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- This deviceK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK091829 PLS Portable Light SourceOptim, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K091829PLS Portable Light SourceOptim, Inc. · 2009 · cites it directly9descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 2 generations on6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 3 generations on5descendants
- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · cites it directly4descendants
- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −1 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| 0 (this device) | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| +1 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| +2 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +3 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +1 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +2 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
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 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K864821 | Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2Summary page 1…Common or Usual Name Nasopharyngoscope Classification Name and Product Code Nasopharyngoscope; EOB Predicate Devices OL-1I Airway Fiberscope, K864821 Vision-Sciences EFl100 nasopharyngoscope, K942265 Vision-Sciences ENT-3 000 nasopharyngoscope, KO050972 Visi… | 1987 |
| * | K942265 | Flexible Nasopharyngo-Laryngoscope and EndosheathSummary page 1…ication Name and Product Code Nasopharyngoscope; EOB Predicate Devices OL-1I Airway Fiberscope, K864821 Vision-Sciences EFl100 nasopharyngoscope, K942265 Vision-Sciences ENT-3 000 nasopharyngoscope, KO050972 Vision-Sciences ENT-5000 nasopharyngoscope, K072073 Purpose… | 1995 |
| * | K050972 | Vision-Sciences Ent-3000 ScopeSummary page 1…Predicate Devices OL-1I Airway Fiberscope, K864821 Vision-Sciences EFl100 nasopharyngoscope, K942265 Vision-Sciences ENT-3 000 nasopharyngoscope, KO050972 Vision-Sciences ENT-5000 nasopharyngoscope, K072073 Purpose of the Special 510(k) Notice The ENTity NasoView is a… | 2005 |
| * | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Summary page 1…Vision-Sciences EFl100 nasopharyngoscope, K942265 Vision-Sciences ENT-3 000 nasopharyngoscope, KO050972 Vision-Sciences ENT-5000 nasopharyngoscope, K072073 Purpose of the Special 510(k) Notice The ENTity NasoView is a modification of the OL-1 Airway Fiberscope.… | 2007 |
What descends from it? (15)
See all 152 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 16 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K091829 (Optim, Inc., 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080622 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080622
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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