510(k) · Cleared
ClearedMelide Fiberoptic Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Designs For Vision, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Aug 15, 2005 as substantially equivalent to K032283 (Designs For Vision, Inc., 2003) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Aug 15, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980281 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK980281 Welch Allyn Xenon 300 Light SourceWelch Allyn, Inc. · 1998
- 2 generations backK013880 Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001
- 1 generation backK032283 Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
- This deviceK051786 Melide Fiberoptic LightDesigns For Vision, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980281 | Welch Allyn Xenon 300 Light Source | Welch Allyn, Inc. | 1998 | — |
| −2 | K013880 | Daylite Xenon Light Sources | Designs For Vision, Inc. | 2001 | — |
| −1 | K032283 | Designs for Vision Fiberoptic Light | Designs For Vision, Inc. | 2003 | — |
| 0 (this device) | K051786 | Melide Fiberoptic Light | Designs For Vision, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 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 FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032283 | Designs for Vision Fiberoptic LightSummary page 1…cal Lights Classification Name: Surgical lamp 3. PREDICATE DEVICES *Designs for Vision Fiberoptic Light K03 2283 *Cuda Products Corporation M300 Light Source K981962 4. DEVICE DESCRIPTION Th… | 2003 |
| * | K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceSummary page 1…CES *Designs for Vision Fiberoptic Light K03 2283 *Cuda Products Corporation M300 Light Source K981962 4. DEVICE DESCRIPTION The Designs for Vision Melide Fiberoptic Light (Melide Fiberoptic Light) is a… | 1998 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051786: Melide Fiberoptic Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051786
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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