510(k) · Cleared
ClearedKsea SCB Media Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FTA Light, Surgical, Accessories
Cleared on May 28, 2002 after a 90-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- May 28, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK020640 Ksea SCB Media ControlKARL STORZ Endoscopy-America, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- Descendant · cites it directly · 2 of its ownK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- Descendant · 2 generations on · 2 of its ownK070556 Brainsuite NetBrainlab AG · 2007
- Descendant · 2 generations on · 1 of its ownK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K033132Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · cites it directly8descendants
- K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010 · cites it directly2descendants
- K070556Brainsuite NetBrainlab AG · 2007 · 2 generations on2descendants
- K161122Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016 · 2 generations on1descendant
- K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020640 | Ksea SCB Media Control | KARL STORZ Endoscopy-America, Inc. | 2002 | — |
| +1 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| +1 | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| +2 | K070556 | Brainsuite Net | Brainlab AG | 2007 | — |
| +2 | K161122 | Sony IP Converter NU-IP40S | Sony Electronics, Inc. | 2016 | — |
| +2 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 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 FTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
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?
- Of its descendants, K033132 (Stryker Communications Corp., 2004) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FTA devicesFTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTA
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FTA
61in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTA
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTA
19in 2025
MAUDE reports naming product code FTA, 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 | 0 | — | 2 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 3 | 61 | 0 | 7 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 1 | 22 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 105 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The KSEA SCB Media Control provides remote control for overhead and surgical lights, cameras, telephones, pagers, CD-players, audio volume output, and teleconference equipment in the operating room.
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/K020640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020640: Ksea SCB Media Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020640
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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