510(k) · Cleared
ClearedModification to Vista Stereoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Medical Technologies, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Feb 12, 2002 as substantially equivalent to K990635 (Vista Medical Technologies, Inc., 1999) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 12, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K923160 (1992). 9 ancestors in all. 2 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 deviceK020301 Modification to Vista Stereoscope SystemVista Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK021290 Vista Visualization System, Model 9000, Vista Visualization System…Vista Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK101810 3DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
Most influential descendants
Showing 2 of 2 · See allView 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) | K020301 | Modification to Vista Stereoscope System | Vista Medical Technologies, Inc. | 2002 | — |
| +1 | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice… | Vista Medical Technologies, Inc. | 2002 | — |
| +2 | K101810 | 3DHJD Camera System Model | Vision Systems Group, A Division of Viking Systems | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K990635 | Vista Stereoscope SystemSummary page 4…Vista Medical Technologies Phone: (508) 366-3668 ext. 8279 Facsimile: (508) 366-8858 Device Name Vista Stereoscope System Predicate Device(s) Vista Stereoscope System (K990635); Vista Single Chip Video Camera (K971373) Device Description The Vista StereoScope System is a device used to allow observatio… | 1999 |
| * | K971373 | Vista Single Chip Video CameraSummary page 4…6-3668 ext. 8279 Facsimile: (508) 366-8858 Device Name Vista Stereoscope System Predicate Device(s) Vista Stereoscope System (K990635); Vista Single Chip Video Camera (K971373) Device Description The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals thro… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation… | 2002 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K021290 (Vista Medical Technologies, Inc., 2002) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K990635.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
The Vista StereoScope System is intended for the 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/K020301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020301: Modification to Vista Stereoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020301
Report an extraction error
Are you the manufacturer?
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