510(k) Report

FDA applicant

Specialized Health Products, Intl.

Bountiful, UT1 decision2005–20052 recalls

FDA records 1 decision for Specialized Health Products, Intl. (Bountiful, UT) in 2005: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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, Intl.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Specialized Health Products, Intl. 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?

  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 20051cites it

What has FDA decided for it lately?

  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 20052 recalls

The one decision as Specialized Health Products, Intl. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K050600MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75.…Dec 19, 2016Class II
  • K040527BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep…Aug 8, 2014Class II

Other applicant names beginning “Specialized”

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

Specialized Health Products, Inc. 4Specialized Assays, Inc. 3Specialized Health Products International, Inc. 2Specialized Laboratory Equipment, Ltd. 2