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

Medix I.C.S.A. — Predicate Candidate Screening

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

236 daysmedian FDA review time

501 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K103735	MEDILED MINI	Medix I.C.S.A.	2011-08-15	236	0
K083179	MEDILED PHOTOTHERAPY LAMP	Medix I.C.S.A.	2009-02-27	122	0
K070291	MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE	Medix I.C.S.A.	2007-09-21	234	2
K931529	INFANT WARMER	Medix I.C.S.A.	1994-03-11	350	0
K931965	MEDIX PHOTOTHERAPY LAMP	Medix I.C.S.A.	1993-12-09	231	0
K920049	MEDIX PC-305 NEONATAL INCUBATOR	Medix I.C.S.A.	1993-05-21	501	0

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