510(k) · Cleared

Cleared

Silverseal Tubular Wound Dressing with X-Static

K043526510(k) TraditionalCleared Mar 10, 200579-day reviewClass I21 CFR 888.5940

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

Noble Fiber Technologies, Inc. · LGF Component, Cast

Cleared on Mar 10, 2005 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Mar 10, 2005
Review: 79 days
Class: Class I
Product code: LGF
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK043526 Silverseal Tubular Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
Descendant · cites it directly · 0 of its ownK051256 Silverseal Orthotic Component with X-StaticNoble Fiber Technologies, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K051256Silverseal Orthotic Component with X-StaticNoble Fiber Technologies, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K043526	Silverseal Tubular Wound Dressing with X-Static	Noble Fiber Technologies, Inc.	2005	—
+1	K051256	Silverseal Orthotic Component with X-Static	Noble Fiber Technologies, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K043526, 2005–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LGF? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K051256	Silverseal Orthotic Component with X-Static	Noble Fiber Technologies, Inc.	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?

Of its descendants, K051256 (Noble Fiber Technologies, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LGF devices

LGF Component, Cast: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGF

FDA has decided no LGF device since 2007.

Median 510(k) review, days · LGF

Too few LGF 510(k)s in any year since 2007 to give a median.

Recalls per year · LGF

No recall names LGF since 2007.

Adverse event reports per year · LGF

1in 2018

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code LGF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K043526 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043526: Silverseal Tubular Wound Dressing with X-Static.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043526

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026