510(k) · Cleared
ClearedVista Visualization System, Model 9000, Vista Visualization System with Voice Activation and Pip, Model 9100
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 Jun 28, 2002 as substantially equivalent to K020301 (Vista Medical Technologies, Inc., 2002) and 2 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Jun 28, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K923160 (1992). 12 ancestors in all. 1 later device descends from it, 1 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 backK020301 Modification to Vista Stereoscope SystemVista Medical Technologies, Inc. · 2002
- This deviceK021290 Vista Visualization System, Model 9000, Vista Visualization System…Vista Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK101810 3DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
Most influential descendants
Showing 1 of 1 · See all- K1018103DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010 · cites it directly0descendants
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 | K020301 | Modification to Vista Stereoscope System | Vista Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice… | Vista Medical Technologies, Inc. | 2002 | — |
| +1 | 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 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K020301 | Modification to Vista Stereoscope SystemSummary page 1…(508) 366-3668 ext. 8279 Facsimile: (508) 366-8858 C. Device Name Vista Visualization System D. Predicate Device(s) Vista Stereoscope System (K020301); Head Mounted Display System (K973436); ORPC with Infomatix IntraOp Software (K991303). E. Device Description T… | 2002 |
| * | K973436 | Vista Head Mounted DisplaySummary page 1…e: (508) 366-8858 C. Device Name Vista Visualization System D. Predicate Device(s) Vista Stereoscope System (K020301); Head Mounted Display System (K973436); ORPC with Infomatix IntraOp Software (K991303). E. Device Description The Vista Visualization System is used t… | 1997 |
| * | K991303 | Vista Orpc with Infomatix Intraop SoftwareSummary page 1…alization System D. Predicate Device(s) Vista Stereoscope System (K020301); Head Mounted Display System (K973436); ORPC with Infomatix IntraOp Software (K991303). E. Device Description The Vista Visualization System is used to allow observation in body cavities, organs, or canal… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101810 | 3DHJD Camera System Model | 2010 | 0 |
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 2.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K101810 (Vision Systems Group, A Division of Viking Systems, 2010) has gone furthest, with 0 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 Visualization System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021290: Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation and Pip, Model 9100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021290
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