510(k) · Cleared
ClearedSCB/Steris or-Light Interface Box
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 Aug 11, 2005 as substantially equivalent to K041912 (KARL STORZ Endoscopy-America, Inc., 2004) after a 65-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Aug 11, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041912 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041912 SCB/Valleylab Force FX Interface UnitKARL STORZ Endoscopy-America, Inc. · 2004
- This deviceK051505 SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK081698 Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK102791 Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK133413 Idss SLCBlack Diamond Video · 2014
- Descendant · 3 generations on · 0 of its ownK112133 Oasys Surgical Light ControllerOasys Healthcare · 2012
Most influential descendants
Showing 4 of 4 · See all- K081698Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008 · cites it directly3descendants
- K102791Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010 · 2 generations on2descendants
- K133413Idss SLCBlack Diamond Video · 2014 · 3 generations on0descendants
- K112133Oasys Surgical Light ControllerOasys Healthcare · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041912 | SCB/Valleylab Force FX Interface Unit | KARL STORZ Endoscopy-America, Inc. | 2004 | — |
| 0 (this device) | K051505 | SCB/Steris or-Light Interface Box | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +1 | K081698 | Mainstream or Surgical Light Control (MSLC) | Image Stream Medical, Inc. | 2008 | — |
| +2 | K102791 | Easysuite Surgical Light Control (Eslc) | Image Stream Medical, Inc. | 2010 | — |
| +3 | K133413 | Idss SLC | Black Diamond Video | 2014 | — |
| +3 | K112133 | Oasys Surgical Light Controller | Oasys Healthcare | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (1)
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 |
|---|---|---|---|
| * | K041912 | SCB/Valleylab Force FX Interface UnitSummary page 1…ns. Substantial Equivalence: The Karl Storz SCB/STERIS OR-Light Interface Box is substantially equivalent to the predicate device SCB/ValleyLabs Force FX Interface Box (K041912) since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/STERIS OR-Light Interf… | 2004 |
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 |
|---|---|---|---|
| K081698 | Mainstream or Surgical Light Control (MSLC) | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K081698 (Image Stream Medical, Inc., 2008) 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 Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STEMIS Harmony LA OR-Lighting System's control parameter on a SCB computer…
Read the full statement (117 words)
The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System.
This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STEMIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051505: SCB/Steris or-Light Interface Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051505
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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