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

Mcgaw, Inc. — Predicate Candidate Screening

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

138 daysmedian FDA review time

354 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972678	MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUM	Mcgaw, Inc.	1997-10-07	83	0
K955595	SAFELINE MULTIDOSE VIAL ADAPTER	Mcgaw, Inc.	1996-03-06	89	0
K955594	SAFELINE I.V. BAG ACCESS DEVICE	Mcgaw, Inc.	1996-03-06	89	0
K941244	SAFELINE SYSTEM TURN LOCK CANNULA	Mcgaw, Inc.	1994-11-29	259	0
K932165	INTRAVASCULAR ADMINISTRATION SET	Mcgaw, Inc.	1994-04-13	344	0
K931377	SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT	Mcgaw, Inc.	1994-03-07	354	12
K932856	IRRIGATION ACCESS CAP	Mcgaw, Inc.	1994-01-26	230	0
K922637	HORIZON PUMP Y-TYPE BLOOD SET	Mcgaw, Inc.	1993-06-04	365	4
K921860	MODIFICATION TO IV SPIKE	Mcgaw, Inc.	1992-07-30	141	6
K913661	MODIFIED VOLUMETRIC INFUSION PUMP	Mcgaw, Inc.	1991-12-18	138	7
K913056	VOLUMETRIC INFUSION PUMP, MODIFICATION	Mcgaw, Inc.	1991-09-06	66	0
K911753	INTERVASCULAR ADMINSTRATION SET	Mcgaw, Inc.	1991-06-24	67	0
K905201	TPN FLUID TRANSFER SET	Mcgaw, Inc.	1991-01-02	43	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