510(k) · Cleared
ClearedOasys Surgical Light Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oasys Healthcare · FTA Light, Surgical, Accessories
Cleared on Mar 1, 2012 as substantially equivalent to K102791 (Image Stream Medical, Inc., 2010) after a 219-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Mar 1, 2012
- Review
- 219 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
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 deviceK112133 Oasys Surgical Light ControllerOasys Healthcare · 2012
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) | K112133 | Oasys Surgical Light Controller | Oasys Healthcare | 2012 | — |
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 |
|---|---|---|---|
| * | K102791 | Easysuite Surgical Light Control (Eslc)Summary page 2…forth based upon operator interaction with the graphical user interface. There are no patient contacting components. Predicate Device: EasySuite Surgical Light Control (K102791) software. Substantial Equivalence: The proposed OASYS Surgical Light Controller Software is substantially equivalent to Image S… | 2010 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.3 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. 2012, 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?
The OASYS Surgical Light Controller Software allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112133: Oasys Surgical Light Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112133
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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