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

Migada, Ltd. — Predicate Candidate Screening

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

69 daysmedian FDA review time

146 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K943095	IV TRANSFER SPIKE	Migada, Ltd.	1994-09-30	94
K933929	LAB-SITE(R) SAFETY CANNULA	Migada, Ltd.	1993-12-07	119
K902881	LAB-SITE SAFETY NEEDLE	Migada, Ltd.	1990-09-26	86
K870016	ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)	Migada, Ltd.	1987-05-28	146
K864453	EMERGENCY & MILITARY INFUSION SYSTEM	Migada, Ltd.	1987-01-20	69
K863304	PRESELECTED FLOW RATE I.V. SET	Migada, Ltd.	1986-12-09	106
K860952	I.V. SET WITH AND WITHOUT AIR VENT	Migada, Ltd.	1986-08-27	167
K861275	HIGH FLOW I.V. SET	Migada, Ltd.	1986-06-02	56
K860595	TRANSFER SET	Migada, Ltd.	1986-04-07	47
K854365	IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS	Migada, Ltd.	1986-03-24	146
K860605	FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER	Migada, Ltd.	1986-03-24	33
K860201	PARENTERAL ADMINISTRATION SET	Migada, Ltd.	1986-02-04	13
K853385	I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT	Migada, Ltd.	1985-08-23	11
K853386	MULTISET 40	Migada, Ltd.	1985-08-22	10
K853387	ET - EXTENSION SETS	Migada, Ltd.	1985-08-22	10

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