510(k) · Cleared

Recalled · 2007

Smith & Nephew Xenon Light Sources and Accessories

K994084510(k) TraditionalCleared Jan 20, 200048-day reviewClass II21 CFR 876.1500Recalls 1

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

Smith & Nephew, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope

Cleared on Jan 20, 2000 after a 48-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.

Decided: Jan 20, 2000
Review: 48 days
Class: Class II
Product code: FFS
Recalls: 1
Predicates: 0

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

This deviceK994084 Smith & Nephew Xenon Light Sources and AccessoriesSmith & Nephew, Inc. · 2000
Descendant · cites it directly · 1 of its ownK032387 Trivex SystemSmith & Nephew, Inc. · 2003 · Recalled
Descendant · 2 generations on · 0 of its ownK212894 PhasTIPPLeMaitre Vascular, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all

K032387Trivex SystemSmith & Nephew, Inc. · 2003 · cites it directly1descendant
K212894PhasTIPPLeMaitre Vascular, Inc. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K994084	Smith & Nephew Xenon Light Sources and Accessories	Smith & Nephew, Inc.	2000	—
+1	K032387	Trivex System	Smith & Nephew, Inc.	2003	1
+2	K212894	PhasTIPP	LeMaitre Vascular, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2022	1	0

FIG. 1 — Lineage of K994084, 2000–2022Source: 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 FFS? 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
*	—	Smith & Nephew Xenon Light Sources, Light Guides and accessories Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K032387	Trivex System	Smith & Nephew, Inc.	2003	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 9, 2007	Not classified	Z-0840-2007	Nonconforming Material/Component	Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K032387 (Smith & Nephew, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FFS devices

FFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFS

3in 2007

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FFS

74in 2007

2007high 74 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FFS

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FFS

5in 2024

2007high 57 (2021) · low 0 (2025)2025

MAUDE reports naming product code FFS, 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	3	74	1	12
2008	0	—	0	17
2009	0	—	0	14
2010	0	—	0	5
2011	0	—	0	7
2012	0	—	0	4
2013	0	—	0	10
2014	0	—	0	5
2015	0	—	0	4
2016	0	—	0	7
2017	0	—	0	19
2018	0	—	0	19
2019	0	—	0	17
2020	0	—	0	56
2021	0	—	0	57
2022	0	—	0	10
2023	0	—	0	6
2024	0	—	0	5
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.

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/K994084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994084: Smith & Nephew Xenon Light Sources and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994084

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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