510(k) Report

FDA applicant

Sheathing Technologies, Inc.

Morgan Hill, CA7 decisions1999–20161 recall

FDA records 7 decisions for Sheathing Technologies, Inc. (Morgan Hill, CA) from 1999 to 2016: 7 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and MUI (Media, Coupling, Ultrasound). Its devices cite 12 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sheathing Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2009: 12010: 12012: 12013: 12016: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sheathing Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sheathing Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic4decisions
  • MUIMedia, Coupling, Ultrasound2decisions
  • FDFColonoscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K112827Sheathes Ultrasond GelSheathing Technologies, Inc. · 20123cite it
  • K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and…Sheathing Technologies, Inc. · 20051cites it
  • K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 20131cites it
  • K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc. · 20101cites it
  • K990175Sheathes (Non-Latex), SterileSheathing Technologies, Inc. · 19991cites it

What has FDA decided for it lately?

  • K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. · 20161 recall
  • K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013
  • K112827Sheathes Ultrasond GelSheathing Technologies, Inc. · 2012
  • K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc. · 2010
  • K091828Sheathesiso Ultrasound Transducer CoverSheathing Technologies, Inc. · 2009
  • K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based on Transducer and…Sheathing Technologies, Inc. · 2005
  • K990175Sheathes (Non-Latex), SterileSheathing Technologies, Inc. · 1999

All 7 as Sheathing Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K153212Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm…Nov 17, 2025Class II