# Medivance, Inc.

- Location (FDA's records): Louisville, CO
- FDA decisions: 12 (2000–2025): 12 510(k) clearances
- Product codes: DWJ (10), NCX (1), FLL (1)
- 510(k) review time since 2016: median 120 days, against 131 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 17 (11 its own); citations of its devices by later devices: 22 (11 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gaymar Industries, Inc.: 2 (https://510kreport.com/company/gaymar-industries)
- Cincinnati Sub-Zero: 1 (https://510kreport.com/company/cincinnati-sub-zero)
- Emcools Emergency Medical Cooling Systems AG: 1 (https://510kreport.com/company/emcools-emergency-medical-cooling-systems)
- Smiths Industries Medical Systems, Inc.: 1 (https://510kreport.com/company/smiths-industries-medical-systems)
- Cincinnati Sub-Zero Products, Inc.: 1 (https://510kreport.com/company/cincinnati-sub-zero-products)

## Firms that cite its devices most
- Innercool Therapies: 1 (https://510kreport.com/company/innercool-therapies)
- Gaymar Industries, Inc.: 1 (https://510kreport.com/company/gaymar-industries)
- Inspiration Healthcare, Ltd.: 1 (https://510kreport.com/company/inspiration-healthcare)
- Radiant Medical: 1 (https://510kreport.com/company/radiant-medical)
- Seiratherm GmbH: 1 (https://510kreport.com/company/seiratherm)
- Emcools Emergency Medical Cooling Systems AG: 1 (https://510kreport.com/company/emcools-emergency-medical-cooling-systems)
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Novocor Medical Systems, Inc.: 1 (https://510kreport.com/company/novocor-medical-systems)

## Its most-cited devices
- K010338: Artic Sun Temperature Management System, Model 200 (2001), cited by 5
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000 (2007), cited by 4
- K101092: Arctic Sun Temperature Management System, Model 5000 (2010), cited by 4
- K002577: Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads (2000), cited by 3
- K080899: Arctic Blast Intravenous Fluid Chiller (2008), cited by 2
- K161602: Arctic Sun Temperature Management System (2016), cited by 2

## Recent decisions
- K251974: Arctic Sun Temperature Management System (Model 5000) (Oct 24, 2025)
- K243942: Arctic Sun Stat Temperature Management System (Apr 30, 2025)
- K200225: Arctic Sun Stat Temperature Management System (Feb 28, 2020)
- K161602: Arctic Sun Temperature Management System (Sep 2, 2016)
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (Dec 18, 2014)
- K120849: Hybrid Arcticgel Pad (Jul 20, 2012)
- K110956: Medivance Nasogastric Tube Temperature Sensor (Jul 18, 2011)
- K101092: Arctic Sun Temperature Management System, Model 5000 (Jul 16, 2010)

Source page: https://510kreport.com/company/medivance