510(k) · Cleared
ClearedVisionsense Stereoscopic Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionsense, Ltd. · HRX Arthroscope
Cleared on Dec 15, 2008 as substantially equivalent to K081102 (Visionsense, Ltd., 2008) and 3 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1992. 37 later devices descend from it.
- Decided
- Dec 15, 2008
- Review
- 122 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K923160 (1992). 12 ancestors in all. 37 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 3 generations backK961182 3D ScopeOktas · 1996
- 2 generations backK970214 3 Dimensional Video EndoscopeOktas · 1997
- 1 generation backK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- This deviceK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · cites it directly · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · 2 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 3 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 4 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 4 generations on · 30 of its ownK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · cites it directly36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 2 generations on34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 3 generations on32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 4 generations on31descendants
- K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −3 | K961182 | 3D Scope | Oktas | 1996 | — |
| −2 | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| −1 | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +1 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +2 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +3 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +4 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +4 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 8 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 2…rthroscope Review Panel: Orthopedic Product Code: IIRX Device Class: Class II \\D 082456/000001 -2829350 v1 Predicate Devices K081102, K073279 V1 -ViinesStrocpcVisionsense Ltd. _________________V… | 2008 |
| * | K073279 | VS-Visionsense Stereoscopic Vision SystemSummary page 2…e Review Panel: Orthopedic Product Code: IIRX Device Class: Class II \\D 082456/000001 -2829350 v1 Predicate Devices K081102, K073279 V1 -ViinesStrocpcVisionsense Ltd. _________________V… | 2008 |
| * | K051827 | Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys…Summary page 2…SystemVista Medical K990635 Vista Streoscope SystemTechnologies K051827 THESSYS Multiscope Joimiax GmbH Intended Use/Indications for Use The VSII System is in… | 2005 |
| * | K990635 | Vista Stereoscope SystemSummary page 2…Vista Streoscop SystemVista Medical K990635 Vista Streoscope SystemTechnologies K051827 THESSYS… | 1999 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141002 | VS3 Stereoscopic High Definition Vision System | 2014 | 36 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K141002 (Visionsense, Ltd., 2014) has gone furthest, with 36 descendants of its own.
- 2 other devices also cite its predicate K081102.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, 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/K082355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082355: Visionsense Stereoscopic Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082355
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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