510(k) Report

FDA applicant

Specialized Health Products, Inc.

Sandy, UT4 decisions1996–20051 recall

FDA records 4 decisions for Specialized Health Products, Inc. (Sandy, UT) from 1996 to 2005: 4 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FPA (Set, Administration, Intravascular). Its devices cite 4 predicates, 0 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, general hospital panel, where it files most

How often FDA has decided Specialized Health Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Specialized Health Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FPASet, Administration, Intravascular1decision
  • DYBIntroducer, Catheter1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 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.

  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 20013cite it
  • K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 20053cite it

What has FDA decided for it lately?

  • K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc. · 2005
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 20011 recall
  • K964042Extresafe PhlebotomySpecialized Health Products, Inc. · 1997
  • K962149Safety CradleSpecialized Health Products, Inc. · 1996

All 4 as Specialized Health Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K013394SHPI LIftLoc Safety Infusion SetsApr 17, 2003

Other applicant names beginning “Specialized”

FDA records each applicant name separately; these may or may not be the same firm.

Specialized Assays, Inc. 3Specialized Health Products International, Inc. 2Specialized Laboratory Equipment, Ltd. 2Specialized Health Products, Intl. 1