510(k) Report

FDA applicant

Arizant Healthcare, Inc.

Eden Prairie, MN6 decisions2004–20128 recalls

FDA records 6 decisions for Arizant Healthcare, Inc. (Eden Prairie, MN) from 2004 to 2012: 6 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 12 predicates, 2 of them its own earlier devices. 8 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2012

2008: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2009: 42017: 12018: 22025: 1
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arizant Healthcare, 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?

  • DWJSystem, Thermal Regulating3decisions
  • LGZWarmer, Thermal, Infusion Fluid2decisions
  • FLLContinuous Measurement Thermometer1decision

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 10 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.

  • K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 20062cite it
  • K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 20062cite it
  • K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 20062cite it
  • K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 20042cite it
  • K1204123M Spoton Temperature Monitoring SystemArizant Healthcare, Inc. · 20121cites it
  • K082217Ranger Rapid Flow Blood/Fluid Warming SystemArizant Healthcare, Inc. · 20081cites it

What has FDA decided for it lately?

  • K1204123M Spoton Temperature Monitoring SystemArizant Healthcare, Inc. · 20121 recall
  • K082217Ranger Rapid Flow Blood/Fluid Warming SystemArizant Healthcare, Inc. · 2008
  • K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc. · 20061 recall
  • K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 20066 recalls
  • K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 20064 recalls
  • K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004

All 6 as Arizant Healthcare, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K0609393M Ranger Irrigation Fluid Warming Set, REF 24750Apr 22, 2025Class II
  • K0608653M Bair Hugger (M) Normothermia System, Sterile Full Access Underbody, Model 63700 The…Jan 23, 2018Class II
  • K0608653M Bair Hugger (M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500…Jan 23, 2018Class II
  • K1204123M Bair Hugger (TM) Normothermia System, Temperature Monitoring System Sensors Model 360…Oct 17, 2017Class II
  • K053645Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power…Dec 17, 2009
  • K053645Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power…Dec 17, 2009