510(k) Report

510(k) · Cleared

Cleared

Silverseal Orthotic Component with X-Static

K051256510(k) TraditionalCleared Jul 21, 200566-day reviewClass I21 CFR 890.3420

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. · ISH Component, External, Limb, Ankle/Foot

Cleared on Jul 21, 2005 as substantially equivalent to K043526 (Noble Fiber Technologies, Inc., 2005) after a 66-day review. Its family tree reaches back 1 generation to 2005.

Decided
Jul 21, 2005
Review
66 days
Class
Class I
Product code
ISH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K043526 (2005). No later device cites it as a predicate yet.

K043526 · Silverseal Tubular Wound Dressing with X-Static · Noble Fiber Technologies, Inc. · 20052006
K043526 · Silverseal Tubular Wound Dressing with X-Static · Noble Fiber Technologies, Inc. · 20050
  1. Root · 1 generation backK043526 Silverseal Tubular Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
  2. This deviceK051256 Silverseal Orthotic Component with X-StaticNoble Fiber Technologies, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K043526Silverseal Tubular Wound Dressing with X-StaticNoble Fiber Technologies, Inc.2005—
0 (this device)K051256Silverseal Orthotic Component with X-StaticNoble Fiber Technologies, Inc.2005—
FIG. 1 — Lineage of K051256, 2005–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 ISH? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K043526Silverseal Tubular Wound Dressing with X-Static
Summary page 1
…EAL" Orthotic Component with X-Static® is substantially equivalent to SILVERSEALJ Tubular Cast Component with X-Static® (K043526, Noble Fiber Technologies, Inc.), with respect to the function, intended use and composition…
Noble Fiber Technologies, Inc.2005—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

How does its category compare?

All ISH devices

ISH Component, External, Limb, Ankle/Foot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ISH

FDA has decided no ISH device since 2007.

Median 510(k) review, days · ISH

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

Recalls per year · ISH

1in 2015

2007: 12012: 22013: 12015: 1
2007high 2 (2012) · low 0 (2008)2026

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

Adverse event reports per year · ISH

3in 2025

2007: 12014: 42015: 42016: 92017: 62018: 72019: 42020: 52021: 32022: 22023: 212024: 52025: 3
2007high 21 (2023) · low 0 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11
20080—00
20090—00
20100—00
20110—00
20120—20
20130—10
20140—04
20150—14
20160—09
20170—06
20180—07
20190—04
20200—05
20210—03
20220—02
20230—021
20240—05
20250—03
20260—0—

What is it indicated for?

SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.

Indications for use as stated in the FDA summary.

More from Noble Fiber Technologies, Inc.

5 FDA decisions under this applicant name. See the company

  • K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc. · 2007
  • K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc. · 2005
  • K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
  • K043526Silverseal Tubular Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005

Recent decisions in ISH

The ISH category page

  • K823396Free Flex Heel Height AdjustorOrthopedic Systems, Inc. · 1982
  • K820505Ankle/Foot ExternalMauch Laboratories, Inc. · 1982
  • K791331The Tucker-Sach Foot and Tucker-Syme FTKiswood Manufacturing, Inc. · 1979

https://510kreport.com/device/K051256 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051256: Silverseal Orthotic Component 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/K051256

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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