510(k) · Cleared
ClearedKarl Storz Autoclavable 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 Feb 4, 2000 as substantially equivalent to K883943 (Medical Concepts, Inc., 1988) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Feb 4, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883943 (1988). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008 · 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) | K994090 | Karl Storz Autoclavable Camera Head | Karl Storz Imaging, Inc. | 2000 | — |
| +1 | K080809 | Iec Medsight and Medbright | Innovative Endoscopy Components, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K883943 | CCM-1 Video Camera SystemSummary page 1…capability, to M.P. Video Autoclaveable Camera Heads. KSI's proposed new camera heads and their indications for use are based upon KSI’s premarket notification numbers, K883943 (single chip) and K950862 (three chip), and its autoclavability based upon M.P. Video's “ Autoclaveable Medicam 900 Digicon Camer… | 1988 |
| * | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television…Summary page 1…Autoclaveable Camera Heads. KSI's proposed new camera heads and their indications for use are based upon KSI’s premarket notification numbers, K883943 (single chip) and K950862 (three chip), and its autoclavability based upon M.P. Video's “ Autoclaveable Medicam 900 Digicon Camera”, premarket notification… | 1995 |
| * | K942358 | Autoclaveable Medicam 900 Digicon CameraSummary page 1…883943 (single chip) and K950862 (three chip), and its autoclavability based upon M.P. Video's “ Autoclaveable Medicam 900 Digicon Camera”, premarket notification number K942358. Signed: C/M Date; IT/S/ZOO Terry Fernandez o 1/31/00 % -/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt… | 1994 |
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 |
|---|---|---|---|
| K080809 | Iec Medsight and Medbright | 2008 | 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 (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled t the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then 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/K994090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994090: Karl Storz Autoclavable Camera Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994090
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