510(k) · Cleared

Cleared

Welch Allyn Xenon 300 Light Source

K980281510(k) TraditionalCleared Feb 27, 199832-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Welch Allyn, Inc. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Feb 27, 1998 after a 32-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.

Decided: Feb 27, 1998
Review: 32 days
Class: Class II
Product code: GCT
Recalls: None
Predicates: 0

3 later devices descend from it, 1 citing it directly.

This deviceK980281 Welch Allyn Xenon 300 Light SourceWelch Allyn, Inc. · 1998
Descendant · cites it directly · 2 of its ownK013880 Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001
Descendant · 2 generations on · 1 of its ownK032283 Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
Descendant · 3 generations on · 0 of its ownK051786 Melide Fiberoptic LightDesigns For Vision, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all

K013880Daylite Xenon Light SourcesDesigns For Vision, Inc. · 2001 · cites it directly2descendants
K032283Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003 · 2 generations on1descendant
K051786Melide Fiberoptic LightDesigns For Vision, Inc. · 2005 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980281	Welch Allyn Xenon 300 Light Source	Welch Allyn, Inc.	1998	—
+1	K013880	Daylite Xenon Light Sources	Designs For Vision, Inc.	2001	—
+2	K032283	Designs for Vision Fiberoptic Light	Designs For Vision, Inc.	2003	—
+3	K051786	Melide Fiberoptic Light	Designs For Vision, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2005	1	0

FIG. 1 — Lineage of K980281, 1998–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	—	Luxtec Model 9300 Xenon Light Source Named without a submission number			—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013880	Daylite Xenon Light Sources	Designs For Vision, Inc.	2001	2

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, K013880 (Designs For Vision, Inc., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GCT devices

GCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCT

1in 2010

2007high 1 (2007) · low 0 (2009)2026

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

2007high 347 (2025) · low 7 (2013)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	MAUDE reports
2007	1	—	32
2008	1	—	29
2009	0	—	153
2010	1	—	21
2011	0	—	132
2012	0	—	36
2013	0	—	7
2014	0	—	11
2015	0	—	8
2016	0	—	15
2017	0	—	14
2018	0	—	20
2019	0	—	18
2020	0	—	114
2021	0	—	149
2022	0	—	158
2023	0	—	200
2024	0	—	296
2025	0	—	347
2026	0	—	—

What is it indicated for?

The Welch Allyn 300 Watt Xenon Light Source is indicated for medical lighting applications requiring a remotely located, high intensity illumination. The device is not indicated for neonate transillumination.

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/K980281 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980281: Welch Allyn Xenon 300 Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980281

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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