510(k) · Cleared
ClearedMainstream or Surgical Light Control (MSLC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image Stream Medical, Inc. · FTA Light, Surgical, Accessories
Cleared on Jul 30, 2008 as substantially equivalent to K051505 (KARL STORZ Endoscopy-America, Inc., 2005) after a 43-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.
- Decided
- Jul 30, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041912 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK041912 SCB/Valleylab Force FX Interface UnitKARL STORZ Endoscopy-America, Inc. · 2004
- 1 generation backK051505 SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005
- This deviceK081698 Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK102791 Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK133413 Idss SLCBlack Diamond Video · 2014
- Descendant · 2 generations on · 0 of its ownK112133 Oasys Surgical Light ControllerOasys Healthcare · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K081698 | Mainstream or Surgical Light Control (MSLC) | Image Stream Medical, Inc. | 2008 | — |
| +1 | K102791 | Easysuite Surgical Light Control (Eslc) | Image Stream Medical, Inc. | 2010 | — |
| +2 | K133413 | Idss SLC | Black Diamond Video | 2014 | — |
| +2 | K112133 | Oasys Surgical Light Controller | Oasys Healthcare | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051505 | SCB/Steris or-Light Interface BoxSummary page 1…2 Product Code: FTA Predicate SCB/Steris OR-Light Interface Box, which was cleared to market in device 510(k) # K051505. Device The MainStream® OR Surgical Light Control (MSLC) is an description optional function in the MainStream… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102791 | Easysuite Surgical Light Control (Eslc) | 2010 | 2 |
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102791 (Image Stream Medical, Inc., 2010) has gone furthest, with 2 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. 2008, this device’s year, is highlighted.
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?
MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control. MSLC is an optional function in the MainStream® OR…
Read the full statement (132 words)
MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.
MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081698: Mainstream or Surgical Light Control (MSLC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081698
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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