510(k) Report

FDA applicant

Innovative Medical Technologies, Inc.

Valrico, FL6 decisions1986–20233 recalls

FDA records 6 decisions for Innovative Medical Technologies, Inc. (Valrico, FL) from 1986 to 2023: 6 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and KPR (System, X-Ray, Stationary). 3 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2023

2013: 12023: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2017

2016: 12017: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Innovative Medical Technologies, 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?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions
  • KPRSystem, X-Ray, Stationary1decision
  • GIOTube, Collection, Capillary Blood1decision
  • FPPStretcher, Hand-Carried1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K123987Improve Blood Collection Set and Improsafe Blood Collection SetInnovative Medical Technologies, Inc. · 20132cite it

What has FDA decided for it lately?

  • K220458UltraFlo-R Push Button Blood Collection SetInnovative Medical Technologies, Inc. · 2023
  • K123987Improve Blood Collection Set and Improsafe Blood Collection SetInnovative Medical Technologies, Inc. · 20133 recalls
  • K972969Quick-Draw Capillary Whole Blood Collection SystemInnovative Medical Technologies, Inc. · 1997
  • K936087Carpal BoxInnovative Medical Technologies, Inc. · 1994
  • K904237Rapid Immobilization Device or R.I.D. SystemInnovative Medical Technologies, Inc. · 1991
  • K854194Imt Ultrasonic Stride MonitorInnovative Medical Technologies, Inc. · 1986

All 6 as Innovative Medical Technologies, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K123987Prevent G Safety Winged Blood Collection Set Glide - Sterile/EOSep 22, 2017Class II
  • K123987Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product…Sep 22, 2017Class II
  • K123987Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product…Oct 19, 2016Class II