510(k) · Cleared
ClearedEntellus Medical Flexible Endoscope and Eyepiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entellus Medical, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 18, 2008 as substantially equivalent to K070752 (KARL STORZ Endoscopy-America, Inc., 2007) and 2 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1993. 5 later devices descend from it.
- Decided
- Sep 18, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K931154 (1993). 27 ancestors in all, the oldest K850978 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 4 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 3 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 2 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 1 generation backK070752 Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007
- This deviceK082569 Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK162916 3NT endoscopy system3nt Medical, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK220004 Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202727 Peregrine Endoscopy System3nt Medical, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK192305 Colibri Endoscopy System3nt Medical, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK102366 Finess EndoscopeEntellus Medical, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K1629163NT endoscopy system3nt Medical, Ltd. · 2017 · cites it directly3descendants
- K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022 · 2 generations on0descendants
- K202727Peregrine Endoscopy System3nt Medical, Ltd. · 2021 · 2 generations on0descendants
- K192305Colibri Endoscopy System3nt Medical, Ltd. · 2020 · 2 generations on0descendants
- K102366Finess EndoscopeEntellus Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −5 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −4 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −3 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −2 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −1 | K070752 | Ksea Miniature Endoscope, Model 11565 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| 0 (this device) | K082569 | Entellus Medical Flexible Endoscope and Eyepiece | Entellus Medical, Inc. | 2008 | — |
| +1 | K162916 | 3NT endoscopy system | 3nt Medical, Ltd. | 2017 | — |
| +2 | K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022 | — |
| +2 | K202727 | Peregrine Endoscopy System | 3nt Medical, Ltd. | 2021 | — |
| +2 | K192305 | Colibri Endoscopy System | 3nt Medical, Ltd. | 2020 | — |
| +1 | K102366 | Finess Endoscope | Entellus Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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? (3)
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 |
|---|---|---|---|
| * | K070752 | Ksea Miniature Endoscope, Model 11565Summary page 1…EOB Predicate Device: The Entellus Medical Flexible Endoscope and Eyepiece issubstantially equivalent to the following devices: - Karl Storz Miniature Endoscope (K070752) • Karl Storz Video Rhino-Laryngoscope System (K072387) * Vision-Sciences Trans-Nasal Esophagoscope with Endosheath Syste… | 2007 |
| * | K072387 | Karl Storz Video Rhino-Laryngscope System, Model 11101 SeriesSummary page 1…oscope and Eyepiece issubstantially equivalent to the following devices: - Karl Storz Miniature Endoscope (K070752) • Karl Storz Video Rhino-Laryngoscope System (K072387) * Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786) Device Description: The Entellus Medical Flexib… | 2007 |
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…rl Storz Miniature Endoscope (K070752) • Karl Storz Video Rhino-Laryngoscope System (K072387) * Vision-Sciences Trans-Nasal Esophagoscope with Endosheath System (K031786) Device Description: The Entellus Medical Flexible Endoscope and Eyepiece consist of a flexible fiber optic scope and eyepiece th… | 2003 |
What descends from it? (5)
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 15 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K162916 (3nt Medical, Ltd., 2017) has gone furthest, with 3 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?
The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082569: Entellus Medical Flexible Endoscope and Eyepiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082569
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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