510(k) Report

FDA applicant

Specialized Health Products International, Inc.

Salt Lake, UT2 decisions2007–20082 recalls

FDA records 2 decisions for Specialized Health Products International, Inc. (Salt Lake, UT) from 2007 to 2008: 2 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FPA (Set, Administration, Intravascular). Its devices cite 7 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Specialized Health Products International, 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?

  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 20083cite it
  • K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 20071cites it

What has FDA decided for it lately?

  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 20082 recalls
  • K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007

All 2 as Specialized Health Products International, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K073050PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety…Mar 13, 2015Class 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 Laboratory Equipment, Ltd. 2Specialized Health Products, Intl. 1