510(k) · Cleared
ClearedKarl Storz Direct Coupled Camera Head
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 Nov 24, 1997 as substantially equivalent to K950862 (Karl Storz Imaging, Inc., 1995) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Nov 24, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883943 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK883943 CCM-1 Video Camera SystemMedical Concepts, Inc. · 1988
- This deviceK973252 Karl Storz Direct Coupled Camera HeadKarl Storz Imaging, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK990154 Karl Storz Direct Coupled Interface (Dci 5) Camera SystemKarl Storz Imaging, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990154Karl Storz Direct Coupled Interface (Dci 5) Camera SystemKarl Storz Imaging, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883943 | CCM-1 Video Camera System | Medical Concepts, Inc. | 1988 | — |
| 0 (this device) | K973252 | Karl Storz Direct Coupled Camera Head | Karl Storz Imaging, Inc. | 1997 | — |
| +1 | K990154 | Karl Storz Direct Coupled Interface (Dci 5) Camera System | Karl Storz Imaging, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television…Summary page 2…lly equivalent to several other camera heads currently in commercial distribution including the camera head in the KSI Tricam Color Endoscopic Television Camera System (K950862) and the camera head in the KSI Telecam Color Endoscopic Television Camera System (K883943). The proposed new KSI camera head is… | 1995 |
| * | K883943 | CCM-1 Video Camera SystemSummary page 2…g the camera head in the KSI Tricam Color Endoscopic Television Camera System (K950862) and the camera head in the KSI Telecam Color Endoscopic Television Camera System (K883943). The proposed new KSI camera head is unique only in that it incorporates into one camera head variations of several features f… | 1988 |
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 |
|---|---|---|---|
| K990154 | Karl Storz Direct Coupled Interface (Dci 5) Camera System | 1999 | 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.
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 (KST) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) and the KSI Telecam SL with IPM (Image Processing Module) video processors. The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including…
Read the full statement (127 words)
The Karl Storz Imaging (KST) Direct Coupled (DCC) Camera Head is a color, television camera head
designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI
DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) and the
KSI Telecam SL with IPM (Image Processing Module) video processors.
The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but
not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes,
choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the
endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into
place. The endoscopic image can be displayed on any standard operating room video monitor.
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/K973252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973252: Karl Storz Direct Coupled 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/K973252
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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