510(k) Report

FDA applicant

Medivance, Inc.

Louisville, CO12 decisions2000–202512 recalls

FDA records 12 decisions for Medivance, Inc. (Louisville, CO) from 2000 to 2025: 12 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and NCX (System, Hypothermia, Intravenous, Cooling). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 11 of them its own earlier devices. 12 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 Medivance, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 12008: 12010: 12011: 12012: 12014: 12016: 12020: 12025: 2
2007high 2 (2025) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2024

2015: 22016: 22017: 42018: 12024: 2
2007high 4 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medivance, 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 Regulating10decisions
  • NCXSystem, Hypothermia, Intravenous, Cooling1decision
  • FLLContinuous Measurement Thermometer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 120 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 11 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.

  • K010338Artic Sun Temperature Management System, Model 200Medivance, Inc. · 20015cite it
  • K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 20074cite it
  • K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 20104cite it
  • K002577Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer PadsMedivance, Inc. · 20003cite it
  • K080899Arctic Blast Intravenous Fluid ChillerMedivance, Inc. · 20082cite it
  • K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 20162cite it

What has FDA decided for it lately?

  • K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025
  • K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2025
  • K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 20201 recall
  • K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 20162 recalls
  • K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal…Medivance, Inc. · 20146 recalls
  • K120849Hybrid Arcticgel PadMedivance, Inc. · 2012
  • K110956Medivance Nasogastric Tube Temperature SensorMedivance, Inc. · 2011
  • K101092Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 20103 recalls

All 12 as Medivance, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K161602Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00…Jun 27, 2024Class II
  • K142702Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CFeb 16, 2024Class II
  • K161602Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a…Jun 13, 2018Class II
  • K142702Medivance (R) ARCTIC SUN (R) ARCTICGEL (TM) Pads: Description, Catalog Number a)…Nov 8, 2017Class II
  • K142702Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains…Oct 16, 2017Class II
  • K142702Arctic Sun ArcticGel Pads - Medium, Product Code 317-07Jun 2, 2017Class III