510(k) · Cleared
ClearedVista Stereoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Medical Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 19, 1999 as substantially equivalent to K931478 (Carl Zeiss, Inc., 1994) and 2 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1992. 41 later devices descend from it.
- Decided
- May 19, 1999
- Review
- 82 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923160 (1992). 6 ancestors in all. 41 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 2 generations backK961182 3D ScopeOktas · 1996
- 1 generation backK970214 3 Dimensional Video EndoscopeOktas · 1997
- This deviceK990635 Vista Stereoscope SystemVista Medical Technologies, Inc. · 1999
- 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
- Descendant · 3 generations on · 34 of its ownK152204 VS3-IR systemVisionsense, Ltd. · 2015
- Descendant · 4 generations on · 32 of its ownK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · 5 generations on · 31 of its ownK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008 · cites it directly37descendants
- K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd. · 2014 · 2 generations on36descendants
- K152204VS3-IR systemVisionsense, Ltd. · 2015 · 3 generations on34descendants
- K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 4 generations on32descendants
- K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −2 | K961182 | 3D Scope | Oktas | 1996 | — |
| −1 | K970214 | 3 Dimensional Video Endoscope | Oktas | 1997 | — |
| 0 (this device) | K990635 | Vista Stereoscope System | Vista Medical Technologies, Inc. | 1999 | — |
| +1 | K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | 2008 | — |
| +2 | K141002 | VS3 Stereoscopic High Definition Vision System | Visionsense, Ltd. | 2014 | — |
| +3 | K152204 | VS3-IR system | Visionsense, Ltd. | 2015 | — |
| +4 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +5 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K931478 | Zeiss Opmi L Stereo-LaparoscopeSummary page 1…REDICATE DEVICE 1. Device Name: Zeiss Endolive System Classification: Class Il Manufacturer: Carl Zeiss, Inc. 305 College Road East Princeton, New Jersey 08540 510(k) #: K931478 and K950985 2. Device Name: Vista 3D Video Endoscope Classification; Class Il Manufacturer: Vista Medical Technologies 134 Flande… | 1994 |
| * | K950985 | Zeiss Endolive Stero EndoscopeSummary page 1…ICE 1. Device Name: Zeiss Endolive System Classification: Class Il Manufacturer: Carl Zeiss, Inc. 305 College Road East Princeton, New Jersey 08540 510(k) #: K931478 and K950985 2. Device Name: Vista 3D Video Endoscope Classification; Class Il Manufacturer: Vista Medical Technologies 134 Flanders Road West… | 1995 |
| * | K970214 | 3 Dimensional Video EndoscopeSummary page 1…and K950985 2. Device Name: Vista 3D Video Endoscope Classification; Class Il Manufacturer: Vista Medical Technologies 134 Flanders Road Westborough, MA 01581 510(k) #: K970214 Page 1 of 2 310(k) 44 Vista Medical Technologies - 510(k) Notification Westborough MA Vista StereoScope System F… | 1997 |
What descends from it? (41)
See all 412 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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K082355 (Visionsense, Ltd., 2008) has gone furthest, with 37 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 | — |
What is it indicated for?
The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic,
thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990635: Vista Stereoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990635
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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