510(k) · Cleared
ClearedVisionsense Stereoscopic Vision System (VS System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionsense, Ltd. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Oct 30, 2008 as substantially equivalent to K081102 (Visionsense, Ltd., 2008) and 2 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Oct 30, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K874215 (1988). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK874215 Endoscopes for Sinus SurgeryRichards Medical Co., Inc. · 1988
- 2 generations backK981751 Sinuscope and AccessoriesHenke Sass Wolf of America, Inc. · 1998
- 1 generation backK032822 Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
- This deviceK082667 Visionsense Stereoscopic Vision System (VS System)Visionsense, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK162410 TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162410TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874215 | Endoscopes for Sinus Surgery | Richards Medical Co., Inc. | 1988 | — |
| −2 | K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | 1998 | — |
| −1 | K032822 | Asap Sinuscope… | Asap Endoscopic Products GmbH | 2004 | — |
| 0 (this device) | K082667 | Visionsense Stereoscopic Vision System (VS System) | Visionsense, Ltd. | 2008 | — |
| +1 | K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K081102 | Vsu - Visionsense Stereoscopic Vision SystemSummary page 1…e and Throat Product Code: EOB Device Class: Class II Predicate Devices 510(k) number Trade orporeyname Manfcue K081102, K073279 VS,, - Visionsense Stereoscopic Visionsense Ltd. __________________V isi… | 2008 |
| * | K073279 | VS-Visionsense Stereoscopic Vision SystemSummary page 1…oat Product Code: EOB Device Class: Class II Predicate Devices 510(k) number Trade orporeyname Manfcue K081102, K073279 VS,, - Visionsense Stereoscopic Visionsense Ltd. __________________V ision _Syste… | 2008 |
| * | K032822 | Asap Sinuscope…Summary page 1…reoscopic Visionsense Ltd. __________________V ision _System_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ K032822 asap ENT Endoscope asap Endoscopic Products GmnbH Intended Use/Indications for Use… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162410 | TIPCAM 1S 3D System | 2017 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K162410 (Karl Storz Endoscopy America, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081102.
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 VS,, is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082667 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082667: Visionsense Stereoscopic Vision System (VS System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082667
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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