Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medivance, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time

129 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251974	Arctic Sun Temperature Management System (Model 5000)	Medivance, Inc.	2025-10-24	120	0
K243942	Arctic Sun Stat Temperature Management System	Medivance, Inc.	2025-04-30	131	0
K200225	Arctic Sun Stat Temperature Management System	Medivance, Inc.	2020-02-28	29	1
K161602	Arctic Sun Temperature Management System	Medivance, Inc.	2016-09-02	85	1
K142702	Arctic Sun Temperature Management System, ArcticGel Pads (Un	Medivance, Inc.	2014-12-18	87	2
K120849	HYBRID ARCTICGEL PAD	Medivance, Inc.	2012-07-20	122	0
K110956	MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR	Medivance, Inc.	2011-07-18	104	0
K101092	ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000	Medivance, Inc.	2010-07-16	87	3
K080899	ARCTIC BLAST INTRAVENOUS FLUID CHILLER	Medivance, Inc.	2008-08-07	129	0
K071341	MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MO	Medivance, Inc.	2007-08-03	81	1
K010338	ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200	Medivance, Inc.	2001-03-07	30	1
K002577	ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL	Medivance, Inc.	2000-10-26	69	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda