510(k) · Cleared
ClearedEndoscopy Video Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Systems Group, A Division of Viking Systems · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jun 20, 2008 as substantially equivalent to K941919 (Oktas, 1994) after a 15-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 20, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941919 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK941919 Oktas Endoscopy Video Camera SystemOktas · 1994
- This deviceK081585 Endoscopy Video Camera SystemVision Systems Group, A Division of Viking Systems · 2008
- 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 |
|---|---|---|---|---|---|
| −1 | K941919 | Oktas Endoscopy Video Camera System | Oktas | 1994 | — |
| 0 (this device) | K081585 | Endoscopy Video Camera System | Vision Systems Group, A Division of Viking Systems | 2008 | — |
| +1 | K101810 | 3DHJD Camera System Model | Vision Systems Group, A Division of Viking Systems | 2010 | — |
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 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? (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 |
|---|---|---|---|
| * | K941919 | Oktas Endoscopy Video Camera SystemSummary page 1…Endoscope and/OrAccessories, ZiCER 876. i aUU Comon/Usual names: Endoscope andAccessories, KUG Predicate Devices: K941919 Oktas Endoscopy Video Camera Device Description: The Endoscopy Video Camera System consists of a camera head and a camera contro… | 1994 |
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?
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. 2008, this device’s year, is highlighted.
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 Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081585: Endoscopy Video Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081585
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