510(k) · Cleared
ClearedAcclarent Cyclops Multi-Angle Endoscope
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 Jan 6, 2011 as substantially equivalent to K080622 (Optim, Inc., 2008) and 4 other predicates after a 311-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- Jan 6, 2011
- Review
- 311 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K921244 (1992). 37 ancestors in all, the oldest K771218 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 2 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 1 generation backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- This deviceK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK132433 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK153701 ULYSS Multi View SinuscopeSopro-Comeg GmbH · 2016
- Descendant · cites it directly · 0 of its ownK133941 Mitek ArthroscopesMedos International SARL · 2014
Most influential descendants
Showing 4 of 4 · See all- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · cites it directly3descendants
- K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014 · 2 generations on1descendant
- K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH · 2016 · 3 generations on0descendants
- K133941Mitek ArthroscopesMedos International SARL · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +1 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +2 | K132433 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2014 | — |
| +3 | K153701 | ULYSS Multi View Sinuscope | Sopro-Comeg GmbH | 2016 | — |
| +1 | K133941 | Mitek Arthroscopes | Medos International SARL | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105Summary page 1…760 Classification Name: Nasopharyngoscope (Flexible or Rigid) Product Code: EOB Predicate Devices: OPTIM Inc. ENTity Nasoview Nasopharyngoscope (K080622) Pollux Endoscopy Inc. Sinuscope (K002214) Optus Sinuscope (K944656)… | 2008 |
| * | K002214 | Sinuscope and BaccessoriesSummary page 1…Product Code: EOB Predicate Devices: OPTIM Inc. ENTity Nasoview Nasopharyngoscope (K080622) Pollux Endoscopy Inc. Sinuscope (K002214) Optus Sinuscope (K944656) Karl Storz Hopkins Rigid Autoclavable Telescope (K93… | 2000 |
| * | K944656 | Optus Sinuscopes and AccessoriesSummary page 1…OPTIM Inc. ENTity Nasoview Nasopharyngoscope (K080622) Pollux Endoscopy Inc. Sinuscope (K002214) Optus Sinuscope (K944656) Karl Storz Hopkins Rigid Autoclavable Telescope (K935279) Stryker Endoscopy Ar… | 1995 |
| * | K935279 | Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid…Summary page 1…Pollux Endoscopy Inc. Sinuscope (K002214) Optus Sinuscope (K944656) Karl Storz Hopkins Rigid Autoclavable Telescope (K935279) Stryker Endoscopy Arthroscope (K093677) Device Description: The Acclarent Cyclops Multi-Angle End… | 1994 |
| * | K093677 | Stryker Arthroscope Cleared while this submission was under review Summary page 1…Optus Sinuscope (K944656) Karl Storz Hopkins Rigid Autoclavable Telescope (K935279) Stryker Endoscopy Arthroscope (K093677) Device Description: The Acclarent Cyclops Multi-Angle Endoscope is a 4mm rigid endoscdpe that has… | 2010 |
What descends from it? (4)
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 19 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K110097 (Acclarent, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K080622.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Acciarent Cyclops Multi-Angle Endoscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx in an operating room enviroment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100577 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100577: Acclarent Cyclops Multi-Angle Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100577
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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