510(k) · Cleared
ClearedDesigns for Vision Fiberoptic Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Designs For Vision, Inc. · GDB Endoscope, Fiber Optic
Cleared on Aug 20, 2003 as substantially equivalent to K013880 (Designs For Vision, Inc., 2001) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Aug 20, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- GDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980281 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980281 Welch Allyn Xenon 300 Light SourceWelch Allyn, Inc. · 1998
- 1 generation backK013880 Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001
- This deviceK032283 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 1 of 1 · See all- K051786Melide Fiberoptic LightDesigns For Vision, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980281 | Welch Allyn Xenon 300 Light Source | Welch Allyn, Inc. | 1998 | — |
| −1 | K013880 | Daylite Xenon Light Sources | Designs For Vision, Inc. | 2001 | — |
| 0 (this device) | K032283 | Designs for Vision Fiberoptic Light | Designs For Vision, Inc. | 2003 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 GDB? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013880 | Daylite Xenon Light Sources | 2001 |
| * | K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceSummary page 1…DEVICES Designs for Vision Daylite Xenon Light Source KO 13880 Cuda Products Corporation M300 Light Source K98 1962 4. DEVICEDESCRIPTION The Designs for Vision Fiberoptic Light is composed of a high intensity light source, fi… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051786 | Melide Fiberoptic Light | 2005 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051786 (Designs For Vision, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GDB devicesGDB Endoscope, Fiber Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDB
FDA has decided no GDB device since 2007.
Median 510(k) review, days · GDB
Too few GDB 510(k)s in any year since 2007 to give a median.
Recalls per year · GDB
No recall names GDB since 2007.
Adverse event reports per year · GDB
1in 2020
MAUDE reports naming product code GDB, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Designs for Vision 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/K032283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032283: Designs for Vision Fiberoptic Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032283
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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