510(k) · Cleared
ClearedCuda Products Corp. Model M300 (M-300) Lightsource
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cuda Products Co. · FSS Light, Surgical, Floor Standing
Cleared on Aug 18, 1998 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 18, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- FSS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK981962 Cuda Products Corp. Model M300 (M-300) LightsourceCuda Products Co. · 1998
- Descendant · cites it directly · 1 of its ownK032283 Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK051786 Melide Fiberoptic LightDesigns For Vision, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981962 | Cuda Products Corp. Model M300 (M-300) Lightsource | Cuda Products Co. | 1998 | — |
| +1 | K032283 | Designs for Vision Fiberoptic Light | Designs For Vision, Inc. | 2003 | — |
| +1 | K051786 | Melide Fiberoptic Light | Designs For Vision, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FSS? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K032283 (Designs For Vision, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FSS devicesFSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FSS
Too few FSS 510(k)s in any year since 2007 to give a median.
Recalls per year · FSS
No recall names FSS since 2007.
Adverse event reports per year · FSS
3in 2025
MAUDE reports naming product code FSS, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981962: Cuda Products Corp. Model M300 (M-300) Lightsource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981962
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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