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

Animas Corp. — Predicate Candidate Screening

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

86 daysmedian FDA review time

317 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K080639	SYMPHONY GLUCOSE MANAGEMENT SYSTEM	Animas Corp.	2008-06-24	110	7
K080587	EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE	Animas Corp.	2008-05-15	73	1
K063674	EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE	Animas Corp.	2007-03-30	109	0
K042873	ANIMAS MODEL IR1250 INSULIN INFUSION PUMP	Animas Corp.	2004-12-10	53	6
K032257	MODEL IR 1200 INSULIN PUMP	Animas Corp.	2003-10-16	86	7
K022394	EZMANAGER PLUS	Animas Corp.	2003-06-05	317	0
K021700	ANIMUS EZSERTER INFUSION SET INSERTER	Animas Corp.	2002-06-04	12	0
K021439	MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWAR	Animas Corp.	2002-05-29	23	1
K012754	EZ SET INFUSION SET	Animas Corp.	2001-08-27	11	0
K993184	R1000 SERIES INSULIN PUMP	Animas Corp.	2000-02-10	140	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