Chrysalis Intelligence · Sponsors · Medivance, Inc.

Medivance, Inc.

Louisville, CO, US · 3 510(k) clearances · 2 recalls

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Total clearances

3

2020-02-28 → 2025-10-24

Last 12 months

1

Product codes

1

Most recent

2025-10-24

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DWJ	System, Thermal Regulating	Class II	Cardiovascular	3	2025-10-24

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2024-06-27

Date	Severity	Status	Recall #	Product	Code	Reason
2024-06-27	Class II	Ongoing	Z-2457-2024	Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-…	—	If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temper…
2024-02-16	Class II	Ongoing	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 …

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2025-10-24	K251974	Arctic Sun Temperature Management System (Model 5000)	DWJ	Class II	Cardiovascular
2025-04-30	K243942	Arctic Sun Stat Temperature Management System	DWJ	Class II	Cardiovascular
2020-02-28	K200225	Arctic Sun Stat Temperature Management System	DWJ	Class II	Cardiovascular