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

Hamilton Medical, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time

392 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040574	GALILEO GOLD	Hamilton Medical, Inc.	2004-10-27	237	0
K001686	GALILEO VENTILATOR	Hamilton Medical, Inc.	2000-06-23	36	0
K982910	HAMILTON MEDICAL GALILEOVENTILATOR	Hamilton Medical, Inc.	1999-09-14	392	0
K990293	ALADDIN II MONITORING OXYGEN/AIR MONITOR	Hamilton Medical, Inc.	1999-03-16	46	0
K960359	ALADDIN MONITORING OXYGEN/AIR MIXER	Hamilton Medical, Inc.	1996-04-24	90	0
K945740	INFANT FLOW SYSTEM	Hamilton Medical, Inc.	1995-03-23	120	3
K901448	VEOLAR VENTILATOR	Hamilton Medical, Inc.	1991-12-20	632	0
K900465	MAX TRANSPORT VENTILATOR	Hamilton Medical, Inc.	1990-06-18	138	0
K894426	LEONARDO INFORMATION SYSTEM	Hamilton Medical, Inc.	1989-09-26	71	0
K894316	AMADEUS VENTILATOR	Hamilton Medical, Inc.	1989-09-22	70	0
K881482	VEOLAR VENTILATOR	Hamilton Medical, Inc.	1988-06-16	69	0
K871792	VEOLAR VENTILATOR	Hamilton Medical, Inc.	1988-04-21	350	0
K861432	VEOLAR VENTILATOR	Hamilton Medical, Inc.	1986-05-06	20	0
K854026	VEDLAR VENTILATOR (MODIFICATION)	Hamilton Medical, Inc.	1985-10-23	58	0
K844809	CONTINUOUS VENTILATOR	Hamilton Medical, Inc.	1985-06-27	182	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