510(k) · Cleared
ClearedVS-Visionsense Stereoscopic Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionsense, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 5, 2008 as substantially equivalent to K002431 (Envision Advanced Medical System, Ltd., 2000) after a 105-day review. Its family tree reaches back 1 generation to 2000. 44 later devices descend from it.
- Decided
- Mar 5, 2008
- Review
- 105 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002431 (2000). 44 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK002431 Elran 01 SystemEnvision Advanced Medical System, Ltd. · 2000
- This deviceK073279 VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · cites it directly · 42 of its ownK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · Recalled
- Descendant · cites it directly · 39 of its ownK123467 VS3Visionsense, Ltd. · 2013
- Descendant · 2 generations on · 38 of its ownK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- Descendant · cites it directly · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 2 generations on · 36 of its ownK141002 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K081102Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly42descendants
- K123467VS3Visionsense, Ltd. · 2013 · cites it directly39descendants
- K131434VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013 · 2 generations on38descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | 2000 | — |
| 0 (this device) | K073279 | VS-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +1 | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | 1 |
| +1 | K123467 | VS3 | Visionsense, Ltd. | 2013 | — |
| +2 | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| +1 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +2 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K002431 | Elran 01 SystemSummary page 1…Facsimile: (202) 637-5910 Date Prepared: November 20, 2007 Predicate Devices ELRAN 01 Stereoscopic Laparoscope (K00243 1), Visionsense Ltd. (previously known as Envision Advanced Medical Systems Ltd.) Intended Use The VS11 System is intended for vi… | 2000 |
What descends from it? (44)
See all 444 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?
- Its one ancestor has no recall.
- Of its descendants, K081102 (Visionsense, Ltd., 2008) has gone furthest, with 42 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The VS11 system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073279 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073279: VS-Visionsense Stereoscopic Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073279
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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