510(k) · Cleared
ClearedImage1 S CCU, Image1 S 4U Camera Head
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 Sep 1, 2020 as substantially equivalent to K160044 (Karl Storz Endoscopy America, Inc., 2016) after a 126-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 1, 2020
- Review
- 126 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944620 (1995). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- 3 generations backK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- 2 generations backK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 1 generation backK160044 Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016
- This deviceK201135 Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023
- Descendant · 2 generations on · 0 of its ownK254242 KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026
- Descendant · 2 generations on · 0 of its ownK253972 IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG · 2026
- Descendant · cites it directly · 0 of its ownK250462 UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited · 2025
Most influential descendants
Showing 4 of 4 · See all- K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023 · cites it directly2descendants
- K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| −3 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| −2 | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −1 | K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| 0 (this device) | K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
| +1 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023 | — |
| +2 | K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026 | — |
| +2 | K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | 2026 | — |
| +1 | K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K160044 | Image1 SPIES SystemSummary page 4…II Class: Product Code: FET Product Code Endoscopic Video Imaging System/Component Name Device Panel: Gastroenterology/Urology Predicate Image1 S (K160044) Device(s): Device The Image1 S camera control unit is a medical device which consists Description: of the Image1… | 2016 |
What descends from it? (4)
2 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K233333 (Karl Storz SE & CO. KG, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K160044.
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. 2020, 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 Image1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image1 S 4U camera head is intended to be attached to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201135: Image1 S CCU, Image1 S 4U Camera Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201135
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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