510(k) · Cleared
ClearedIdss SLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Black Diamond Video · FTA Light, Surgical, Accessories
Cleared on Jan 7, 2014 as substantially equivalent to K102791 (Image Stream Medical, Inc., 2010) after a 61-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jan 7, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K041912 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK041912 SCB/Valleylab Force FX Interface UnitKARL STORZ Endoscopy-America, Inc. · 2004
- 3 generations backK051505 SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005
- 2 generations backK081698 Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008
- 1 generation backK102791 Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010
- This deviceK133413 Idss SLCBlack Diamond Video · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041912 | SCB/Valleylab Force FX Interface Unit | KARL STORZ Endoscopy-America, Inc. | 2004 | — |
| −3 | 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 | — |
| −1 | K102791 | Easysuite Surgical Light Control (Eslc) | Image Stream Medical, Inc. | 2010 | — |
| 0 (this device) | K133413 | Idss SLC | Black Diamond Video | 2014 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102791 | Easysuite Surgical Light Control (Eslc)Summary page 1…and Plastic Surgery CFR section: 21 CFR 878.4580 Class: 2 Product Code: FTA Predicate Device: Easy Suite Surgical Light Control (K 10279 1) OASYS Surgical Light Controller (K] 12133) Device Description: IDSS SLC is an additional function of t… | 2010 |
| Kept off the family tree | K12133 | OASYS Surgical Light Controller Number could not be read Summary page 1…2 Product Code: FTA Predicate Device: Easy Suite Surgical Light Control (K 10279 1) OASYS Surgical Light Controller (K] 12133) Device Description: IDSS SLC is an additional function of the IDSS, which is an integrated operating ro… |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K102791.
How does its category compare?
All FTA devicesFTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133413: Idss SLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133413
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