Data / Medical devices / United States / Medivance, Inc.
Medivance, Inc.: FDA-registered device maker in Louisville, CO, United States, 5 510(k) clearances
Medivance, Inc. is registered with the FDA (registration 1725056) in Louisville, CO, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 24, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1725056
- FEI number
- 3003329224
- Address
- 321 South Taylor Avenue Suite 200, Louisville, CO, United States, 80027
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Specification developer
- First device listed
- January 8, 2015
- Registered through
- 2027
- Brand names listed
- Arctic Sun Cleaning Solution, Arctic Sun Stat Temperature Management System, Arctic Sun Temperature Management System, Arctic Sun Temperature Management System (Model 5000), ArcticGel Pads
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Specification developer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2025 | K251974 | Arctic Sun Temperature Management System (Model 5000) | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| April 30, 2025 | K243942 | Arctic Sun Stat Temperature Management System | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| February 28, 2020 | K200225 | Arctic Sun Stat Temperature Management System | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| September 2, 2016 | K161602 | Arctic Sun Temperature Management System | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
| December 18, 2014 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | DWJ | Substantially Equivalent | Medivance, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 27, 2024 | 94881 | Class II | Ongoing | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arct | If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software upd | accessdata.fda.gov |
| February 16, 2024 | 94030 | Class II | Ongoing | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C | Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system. | accessdata.fda.gov |
| January 5, 2005 | 30896 | Not yet classified | Terminated | Arctic Sun Temperature Management System | Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.