510(k) · Cleared
ClearedKsi's New Camera Architecture (Nca) Video Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Imaging, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Apr 27, 2001 after a 185-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 57 devices in its family, counting itself, has a Class I recall. 56 later devices descend from it.
- Decided
- Apr 27, 2001
- Review
- 185 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 3 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- This deviceK003325 Ksi's New Camera Architecture (Nca) Video Imaging SystemKarl Storz Imaging, Inc. · 2001
- Descendant · cites it directly · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 23 of its ownK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 11 of its ownK141250 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- Descendant · 3 generations on · 7 of its ownK142556 Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor3 generations on · 2024
Most influential descendants
Showing 5 of 56 · See all- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · cites it directly53descendants
- K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017 · 2 generations on23descendants
- K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · 2 generations on11descendants
- K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018 · 2 generations on9descendants
- K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003325 | Ksi's New Camera Architecture (Nca) Video Imaging System | Karl Storz Imaging, Inc. | 2001 | — |
| +1 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +2 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| +2 | K141250 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | 2 |
| +2 | K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018 | — |
| +3 | K142556 | Flexible Video-Uretero-Choledochoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 1 |
| 2025 | 14 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (56)
See all 563 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K131369 (KARL STORZ Endoscopy-America, Inc., 2013) has gone furthest, with 53 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.
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 Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system which can be used with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. Any compatible NCA camera head may be used with the NCA KSI Camera Control Unit…
Read the full statement (108 words)
The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system which can be used with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. Any compatible NCA camera head may be used with the NCA KSI Camera Control Unit (CCU). The endoscopic image can be displayed on any standard operating room video monitor.
All standard endoscopic light sources may be used with New Camera Architecture (NCA) camera heads. Both single chip and three chip camera heads will be available in NTSC and PAL configurations.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K003325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003325: Ksi's New Camera Architecture (Nca) Video Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003325
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026