510(k) · Cleared
ClearedMicroendoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Oct 24, 2006 as substantially equivalent to K002214 (Pollux Endoscopy, Inc., 2000) and 2 other predicates after a 14-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Oct 24, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K002214 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002214 Sinuscope and BaccessoriesPollux Endoscopy, Inc. · 2000
- This deviceK063078 MicroendoscopeAcclarent, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK183264 Flex-THOR scopeKARL STORZ Endoscopy-America, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002214 | Sinuscope and Baccessories | Pollux Endoscopy, Inc. | 2000 | — |
| 0 (this device) | K063078 | Microendoscope | Acclarent, Inc. | 2006 | — |
| +1 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
| +2 | K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K002214 | Sinuscope and BaccessoriesSummary page 1…4.4760 Classification Name: Nasopharyngoscope (flexible or rigid) and accessories Product Code: BOB Predicate Device: Pollux Endoscopy Sinuscope (K002214) Acueity ViaDuct MicroEndoscope and Accessories (KO0 1189) EBI VueCath Spinal E… | 2000 |
| * | K011189 | Viaduct Microendoscope and Accessories Our reading of the summary gave K001189, FDA’s number for Modification to Convertors Surgical Gowns (Allegiance Healthcare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acueity ViaDuct MicroEndoscope and Accessories”. | 2001 |
| * | K010179 | Ebi Vuecath Spinal Endoscopic SystemSummary page 1…opy Sinuscope (K002214) Acueity ViaDuct MicroEndoscope and Accessories (KO0 1189) EBI VueCath Spinal Endoscopic System (K010179) Device Description: The MicroEndoscope is a semi-rigid fiberscope that allows for visualization of… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models… | 2011 | 1 |
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?
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 MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063078: Microendoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063078
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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