Medivance Inc.
Louisville, CO, US
MEDIVANCE, INC. appears in FDA device records in Louisville, CO. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Medivance Inc. between 2000 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000) | DWJ | Substantially Equivalent | |
| K243942 | Arctic Sun Stat Temperature Management System | DWJ | Substantially Equivalent | |
| K200225 | Arctic Sun Stat Temperature Management System | DWJ | Substantially Equivalent | |
| K161602 | Arctic Sun Temperature Management System | DWJ | Substantially Equivalent | |
| 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 | |
| K120849 | HYBRID ARCTICGEL PAD | DWJ | Substantially Equivalent | |
| K110956 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 | DWJ | Substantially Equivalent | |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | NCX | Substantially Equivalent | |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | DWJ | Substantially Equivalent | |
| K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 | DWJ | Substantially Equivalent | |
| K002577 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS | DWJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1725056 | 3003329224 | MEDIVANCE, INC. | 321 SOUTH TAYLOR AVENUE, LOUISVILLE, CO 80027 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2457-2024 | 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; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08 | 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 update will be released to correct issue. | Class II | Open, Classified | |
| Z-1381-2024 | 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. | Class II | Open, Classified | |
| Z-0436-05 | Arctic Sun Temperature Management System | Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medivance Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain