510(k) · Cleared
ClearedSCB/Valleylab Force FX Interface Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · ODA Endoscopic Central Control Unit
Cleared on Oct 25, 2004 after a 102-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Oct 25, 2004
- Review
- 102 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK041912 SCB/Valleylab Force FX Interface UnitKARL STORZ Endoscopy-America, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK051505 SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · 2 generations on · 3 of its ownK081698 Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK102791 Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK133413 Idss SLCBlack Diamond Video · 2014
- Descendant · 4 generations on · 0 of its ownK112133 Oasys Surgical Light ControllerOasys Healthcare · 2012
Most influential descendants
Showing 5 of 5 · See all- K051505SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005 · cites it directly4descendants
- K081698Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008 · 2 generations on3descendants
- K102791Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010 · 3 generations on2descendants
- K133413Idss SLCBlack Diamond Video · 2014 · 4 generations on0descendants
- K112133Oasys Surgical Light ControllerOasys Healthcare · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041912 | SCB/Valleylab Force FX Interface Unit | KARL STORZ Endoscopy-America, Inc. | 2004 | — |
| +1 | K051505 | SCB/Steris or-Light Interface Box | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +2 | K081698 | Mainstream or Surgical Light Control (MSLC) | Image Stream Medical, Inc. | 2008 | — |
| +3 | K102791 | Easysuite Surgical Light Control (Eslc) | Image Stream Medical, Inc. | 2010 | — |
| +4 | K133413 | Idss SLC | Black Diamond Video | 2014 | — |
| +4 | K112133 | Oasys Surgical Light Controller | Oasys Healthcare | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 ODA? 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 ODA device
- #1 K203566 Tablet Applicationscore 6.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051505 | SCB/Steris or-Light Interface Box | 2005 | 4 |
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, K051505 (KARL STORZ Endoscopy-America, Inc., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · ODA
Too few ODA 510(k)s in any year since 2007 to give a median.
Recalls per year · ODA
No recall names ODA since 2007.
Adverse event reports per year · ODA
3in 2025
MAUDE reports naming product code ODA, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041912: SCB/Valleylab Force FX Interface Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041912
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