510(k) · Cleared
ClearedElran 01 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envision Advanced Medical System, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 24, 2000 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.
- Decided
- Oct 24, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 1 citing it directly.
- This deviceK002431 Elran 01 SystemEnvision Advanced Medical System, Ltd. · 2000
- Descendant · cites it directly · 44 of its ownK073279 VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
- Descendant · 2 generations on · 42 of its ownK081102 Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 39 of its ownK123467 VS3Visionsense, Ltd. · 2013
- Descendant · 3 generations on · 38 of its ownK131434 VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013
- Descendant · 2 generations on · 37 of its ownK082355 Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K073279VS-Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly44descendants
- K081102Vsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · 2 generations on42descendants
- K123467VS3Visionsense, Ltd. · 2013 · 2 generations on39descendants
- K131434VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2013 · 3 generations on38descendants
- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002431 | Elran 01 System | Envision Advanced Medical System, Ltd. | 2000 | — |
| +1 | K073279 | VS-Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +2 | K081102 | Vsu - Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | 1 |
| +2 | K123467 | VS3 | Visionsense, Ltd. | 2013 | — |
| +3 | K131434 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2013 | — |
| +2 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 451 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073279 | VS-Visionsense Stereoscopic Vision System | 2008 | 44 |
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?
- Of its descendants, K073279 (Visionsense, Ltd., 2008) has gone furthest, with 44 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.
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 | — |
https://510kreport.com/device/K002431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002431: Elran 01 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002431
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026