510(k) · Cleared
ClearedDaylite Xenon Light Sources
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Designs For Vision, Inc. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Dec 7, 2001 as substantially equivalent to K992050 (Walter Lorenz Surgical, Inc., 1999) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Dec 7, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980281 (1998). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980281 Welch Allyn Xenon 300 Light SourceWelch Allyn, Inc. · 1998
- This deviceK013880 Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK032283 Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
- Descendant · 2 generations on · 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 |
|---|---|---|---|---|---|
| −1 | K980281 | Welch Allyn Xenon 300 Light Source | Welch Allyn, Inc. | 1998 | — |
| 0 (this device) | K013880 | Daylite Xenon Light Sources | Designs For Vision, Inc. | 2001 | — |
| +1 | K032283 | Designs for Vision Fiberoptic Light | Designs For Vision, Inc. | 2003 | — |
| +2 | K051786 | Melide Fiberoptic Light | Designs For Vision, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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 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 GCT? 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 |
|---|---|---|---|
| * | K992050 | Lumenon Xenon Light SourceSummary page 1…Usual Name: Surgical Lights Classification Name: Surgical Lights/Routine Fiberoptic Lights 3. PREDICATE DEVICES Walter Lorenz Surgical Inc. Lumenon Xenon Light Source K992050 Welch Allyn, Inc. Xenon 300 Light Source K980281 4. DEVICE DESCRIPTION The Daylite XeNon Light Sources are comprised of high in… | 1999 |
| * | K980281 | Welch Allyn Xenon 300 Light SourceSummary page 1…Surgical Lights/Routine Fiberoptic Lights 3. PREDICATE DEVICES Walter Lorenz Surgical Inc. Lumenon Xenon Light Source K992050 Welch Allyn, Inc. Xenon 300 Light Source K980281 4. DEVICE DESCRIPTION The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables an… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032283 | Designs for Vision Fiberoptic Light | 2003 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K032283 (Designs For Vision, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GCT devicesGCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GCT
Too few GCT 510(k)s in any year since 2007 to give a median.
Recalls per year · GCT
No recall names GCT since 2007.
Adverse event reports per year · GCT
347in 2025
MAUDE reports naming product code GCT, 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 | 32 |
| 2008 | 1 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 132 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 149 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 0 | 200 |
| 2024 | 0 | — | 0 | 296 |
| 2025 | 0 | — | 0 | 347 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013880: Daylite Xenon Light Sources.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013880
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026