510(k) · Cleared
ClearedULYSS Multi View Sinuscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sopro-Comeg GmbH · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 9, 2016 as substantially equivalent to K132433 (Acclarent, Inc., 2014) after a 261-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Sep 9, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921244 (1992). 40 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations between
- 3 generations backK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 2 generations backK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 1 generation backK132433 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014
- This deviceK153701 ULYSS Multi View SinuscopeSopro-Comeg GmbH · 2016
Show all 10 generations
- Root · 10 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 9 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 8 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 7 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 6 generations backK024095 Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2003
- 5 generations backK072073 Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with…Vision-Sciences, Inc. · 2007
- 4 generations backK080622 Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc. · 2008
- 3 generations backK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 2 generations backK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- 1 generation backK132433 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2014
- This deviceK153701 ULYSS Multi View SinuscopeSopro-Comeg GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −9 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −8 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −7 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −6 | K024095 | Modification to Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −5 | K072073 | Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System… | Vision-Sciences, Inc. | 2007 | — |
| −4 | K080622 | Entity Nasoview Led Nasopharyngoscope, Model 006105 | Optim, Inc. | 2008 | — |
| −3 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| −2 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| −1 | K132433 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2014 | — |
| 0 (this device) | K153701 | ULYSS Multi View Sinuscope | Sopro-Comeg GmbH | 2016 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K132433 | Acclarent Cyclops Multi-Angle EndoscopeSummary page 4…Name: accessories Regulation Number 21 CFR 874.4760 Product Code EOB Predicate Device: K132433 –Acclarent Cyclops Multi-Angle Endoscope Reference Device: K944656 – Optus Sinuscopes and Accessories Device T… | 2014 |
| † | K944656 | Optus Sinuscopes and Accessories | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 40 ancestors has a recall of any class.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153701: ULYSS Multi View Sinuscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153701
Report an extraction error
Are you the manufacturer?
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