510(k) · Cleared
ClearedImage 1 Video Imaging System with Optional Insufflators Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on May 31, 2007 after a 78-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- May 31, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK070716 Image 1 Video Imaging System with Optional Insufflators ControlKARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK160044 Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK201135 Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023
- Descendant · cites it directly · 2 of its ownK182696 Telepack X LEDKARL STORZ Endoscopy-America, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K131953IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · cites it directly10descendants
- K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016 · 2 generations on6descendants
- K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc. · 2020 · 3 generations on4descendants
- K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023 · 4 generations on2descendants
- K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070716 | Image 1 Video Imaging System with Optional Insufflators Control | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +2 | K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| +3 | K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
| +4 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023 | — |
| +1 | K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K131953 (KARL STORZ Endoscopy-America, Inc., 2013) has gone furthest, with 10 descendants of its own.
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. 2007, 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 Karl Storz Image 1® Video Imaging System with optional insufflators control allows remote control of Karl Storz insufflators by image 1® camera head control buttons. The Karl Storz Image 1® Video Imaging System is a color video camera system which can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head is directly coupled to the endoscope. Any compatible Image 1® camera head may be used with the Image 1® Karl Storz Camera Control units (CCU). The endoscopic image can be displayed on any standard operating room video monitor and all standard endoscopic light sources may be used with the Image 1® camera head.
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/K070716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070716: Image 1 Video Imaging System with Optional Insufflators Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070716
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