510(k) · Cleared
ClearedSinuscope and Baccessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pollux Endoscopy, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Nov 21, 2000 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 21, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK002214 Sinuscope and BaccessoriesPollux Endoscopy, Inc. · 2000
- 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
- Descendant · cites it directly · 2 of its ownK063078 MicroendoscopeAcclarent, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK132433 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK100533 Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86…Vibrynt, Inc. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · cites it directly4descendants
- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on3descendants
- K063078MicroendoscopeAcclarent, Inc. · 2006 · cites it directly2descendants
- K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014 · 3 generations on1descendant
- K100533Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models…Vibrynt, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002214 | Sinuscope and Baccessories | Pollux Endoscopy, Inc. | 2000 | — |
| +1 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +2 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +1 | K063078 | Microendoscope | Acclarent, Inc. | 2006 | — |
| +3 | K132433 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2014 | — |
| +2 | K100533 | Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM… | Vibrynt, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K100577 (Acclarent, Inc., 2011) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K002214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002214: Sinuscope and Baccessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002214
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026