510(k) · Cleared
ClearedVS3 Stereoscopic High Definition 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 Jun 26, 2014 as substantially equivalent to K131434 (Visionsense, Ltd., 2013) and 2 other predicates after a 69-day review. Its family tree reaches back 5 generations to 1992. 36 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 69 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K923160 (1992). 16 ancestors in all. 36 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 4 generations backK961182 3D ScopeOktas · 1996
- 3 generations backK970214 3 Dimensional Video EndoscopeOktas · 1997
- 2 generations backK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- 1 generation backK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- This deviceK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
- Descendant · cites it directly · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 2 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 3 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 3 generations on · 30 of its ownK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
- Descendant · 4 generations on · 19 of its ownK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K152204VS3-IR systemVisionsense, Ltd. · 2015 · cites it directly34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 2 generations on32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 3 generations on31descendants
- K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018 · 3 generations on30descendants
- K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker · 2021 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −4 | K961182 | 3D Scope | Oktas | 1996 | — |
| −3 | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| −2 | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| −1 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| 0 (this device) | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +1 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +2 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +3 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +3 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
| +4 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable… | Stryker | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K131434 | VS3 Stereoscopic High Definition Vision SystemSummary page 1…General and Plastic Surgery Product Code: HRX Device Class: Class 11 Regulation: 21 C.F.R. §888.1100 Predicate Device Information Visionsense Ltd V53 for Neurosurgery (K13 1434) Visionsense Ltd VSii Arthroscope (K082355) Karl Storz C-Mount Arthroscope (K983 142) Intended Use/Indications for Use The V53-O… | 2013 |
| * | K082355 | Visionsense Stereoscopic Vision SystemSummary page 1…RX Device Class: Class 11 Regulation: 21 C.F.R. §888.1100 Predicate Device Information Visionsense Ltd V53 for Neurosurgery (K13 1434) Visionsense Ltd VSii Arthroscope (K082355) Karl Storz C-Mount Arthroscope (K983 142) Intended Use/Indications for Use The V53-OT system is intended for viewing internal s… | 2008 |
| * | K983142 | Ksea C-Mount ArthroscopesSummary page 1…C.F.R. §888.1100 Predicate Device Information Visionsense Ltd V53 for Neurosurgery (K13 1434) Visionsense Ltd VSii Arthroscope (K082355) Karl Storz C-Mount Arthroscope (K983 142) Intended Use/Indications for Use The V53-OT system is intended for viewing internal surgical sites during general surgical proc… | 1998 |
What descends from it? (36)
See all 362 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 22 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K152204 (Visionsense, Ltd., 2015) has gone furthest, with 34 descendants of its own.
- 2 other devices also cite its predicate K131434.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and focraminotomny, and shoulder and knee arthroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141002: VS3 Stereoscopic High Definition 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/K141002
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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