510(k) · Cleared
Recalled · Class II · 2016IMAGE1 Spies
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 Dec 20, 2013 as substantially equivalent to K070716 (KARL STORZ Endoscopy-America, Inc., 2007) and 1 other predicate after a 176-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- FET
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944620 (1995). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995 · Recalled
- 1 generation backK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- This deviceK131953 IMAGE1 SpiesKARL STORZ Endoscopy-America, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK160044 Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK201135 Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc. · 2020
- Descendant · 3 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 · 1 of its ownK190648 Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK254242 KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. · 2016 · cites it directly6descendants
- K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc. · 2020 · 2 generations on4descendants
- K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023 · 3 generations on2descendants
- K190648Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd. · 2019 · cites it directly1descendant
- K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | 2 |
| −1 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| 0 (this device) | K131953 | IMAGE1 Spies | KARL STORZ Endoscopy-America, Inc. | 2013 | — |
| +1 | K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016 | — |
| +2 | K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
| +3 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023 | — |
| +1 | K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | 2019 | — |
| +4 | K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K070716 | Image 1 Video Imaging System with Optional Insufflators ControlSummary page 2…er than the receptacle of the H-3-Link. Summary of Technological Characteristics: The Imagel SPIES is a modification of the already cleared Imagel Video Imaging System (K070716). The underlying fundamental technology and intended use remains unchanged. All the changes were made to enhance image quality an… | 2007 |
| * | K102466 | Fujinon Epx-4440HD Digital Video ProcessorSummary page 2…e performed to ensure the safety and efficacy of the device. The Imagel SPIES is also substantially equivalent to Eujinon EPX-4440HD Video Processor and Light Source (K(102466). Both devices consist of a video processor (CCU) and a keyboard. They also share the same indications for use and fundamental te… | 2011 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2016 | Class II | Z-2134-2016 | Device Design | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K160044 (Karl Storz Endoscopy America, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K070716.
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. 2013, 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 Imagel SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131953: IMAGE1 Spies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131953
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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