510(k) · Cleared
Recalled · 2007Vista Single Chip Video Camera
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 May 20, 1997 as substantially equivalent to K946171 (Oktas, 1995) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- May 20, 1997
- Review
- 36 days
- Class
- Class II
- Product code
- FET
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946171 (1995). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK946171 Video Endoscope System with ZoomOktas · 1995
- This deviceK971373 Vista Single Chip Video CameraVista Medical Technologies, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK020301 Modification to Vista Stereoscope SystemVista Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK021290 Vista Visualization System, Model 9000, Vista Visualization System…Vista Medical Technologies, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK101810 3DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
Most influential descendants
Showing 3 of 3 · See all- K020301Modification to Vista Stereoscope SystemVista Medical Technologies, Inc. · 2002 · cites it directly2descendants
- K021290Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation…Vista Medical Technologies, Inc. · 2002 · 2 generations on1descendant
- K1018103DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946171 | Video Endoscope System with Zoom | Oktas | 1995 | — |
| 0 (this device) | K971373 | Vista Single Chip Video Camera | Vista Medical Technologies, Inc. | 1997 | — |
| +1 | K020301 | Modification to Vista Stereoscope System | Vista Medical Technologies, Inc. | 2002 | — |
| +2 | K021290 | Vista Visualization System, Model 9000, Vista Visualization System with Voice… | Vista Medical Technologies, Inc. | 2002 | — |
| +3 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K946171 | Video Endoscope System with ZoomSummary page 1…REDICATE DEVICE 1. Device Name: Oktas Classification: Endoscopes and Accessories - 21 CFR 876.1500 Manufacturer: Oktas 134 Flanders Rd Westborough, MA 01581 510(k) #: K946171 2. Device Name: Olympus OTV-S5 Video System Classification: Endoscope and Accessories Manufacturer: Olympus Endoscope Division… | 1995 |
| * | K955404 | Otv-S5 Oes Video SystemSummary page 1…-S5 Video System Classification: Endoscope and Accessories Manufacturer: Olympus Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 510(k) #: K955404 Page 1 of 2 510(k)-Rev. A. 39 ———ote st KNT7/373 2 of-2 Vista Medical Technologies 510&) Notification Westbo… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020301 | Modification to Vista Stereoscope System | 2002 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2007 | Not classified | Z-0699-2007 | Other | A teal "bloom"/ glare on the subject image during high light conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Single Chip Camera System is intended for use with optical endoscopes to
provide a video image of the target area.
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/K971373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971373: Vista Single Chip Video Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971373
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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