510(k) · Cleared
ClearedKsea SCB Acc 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 Jan 30, 2003 after an 87-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jan 30, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK023704 Ksea SCB Acc ControlKARL STORZ Endoscopy-America, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK050829 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
- Descendant · 2 generations on · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
- Descendant · 2 generations on · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
- Descendant · 3 generations on · 0 of its ownK091648 Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009
Most influential descendants
Showing 4 of 4 · See all- K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · cites it directly3descendants
- K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · 2 generations on2descendants
- K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006 · 2 generations on1descendant
- K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis) · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023704 | Ksea SCB Acc Control | KARL STORZ Endoscopy-America, Inc. | 2003 | — |
| +1 | K050829 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
| +2 | K052740 | Nurse's Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2005 | — |
| +2 | K060717 | Nurse Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2006 | — |
| +3 | K091648 | Nurse's Assistant O.R. Control System ,1.8 | Conmed Integrated Systems (Cmis) | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050829 | Nurse's Assistant 1.7 O.R. Control System | 2005 | 3 |
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, K050829 (Conmed Integrated Systems (Cmis), 2005) has gone furthest, with 3 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 ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023704: Ksea SCB Acc Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023704
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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