510(k) · Cleared
ClearedVista Illumination System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Medical Technologies, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on Apr 2, 1997 as substantially equivalent to K933405 (Cogent Light Technologies, Inc., 1994) after a 71-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 2, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933405 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933405 Cogent Light Illuminator 10010 Xenon Light SourceCogent Light Technologies, Inc. · 1994
- This deviceK970217 Vista Illumination SystemVista Medical Technologies, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933405 | Cogent Light Illuminator 10010 Xenon Light Source | Cogent Light Technologies, Inc. | 1994 | — |
| 0 (this device) | K970217 | Vista Illumination System | Vista Medical Technologies, Inc. | 1997 | — |
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 FFS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K933405 | Cogent Light Illuminator 10010 Xenon Light SourceSummary page 1…10 Xenon Light Source and Fiberoptic Cable ifluminator, Fiberoptic for Endoscope Cogent Light Technologies, Inc. 650 S. San Vicente Bivd. Los Angeles, CA 90048-4620 K933405 Page 1 of 2 510(K) 28 """"" Vista Medical Technologies 510(k) Notification Westborough, MA lllumination Syst… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, 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 | 3 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps. It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.
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/K970217 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970217: Vista Illumination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970217
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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