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

Hamilton Medical AG · Predicate Candidate Screening

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

211 daysmedian FDA review time

452 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201306	HAMILTON-C3	Hamilton Medical AG	2021-02-05	266	1
K201658	Hamilton-C6	Hamilton Medical AG	2020-12-11	176	4
K193228	Hamilton-G5	Hamilton Medical AG	2020-05-04	164	0
K181216	HAMILTON-T1, HAMILTON-C1	Hamilton Medical AG	2019-08-02	452	5
K163283	HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010	Hamilton Medical AG	2017-09-20	303	0
K161450	HAMILTON-C3	Hamilton Medical AG	2017-04-27	337	0
K153046	HAMILTON-MR1	Hamilton Medical AG	2016-09-06	323	1
K152029	HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC	Hamilton Medical AG	2016-05-03	286	0
K150893	IntelliCuff	Hamilton Medical AG	2016-01-29	302	1
K140939	HAMILTON-T1,HAMILTON-C1	Hamilton Medical AG	2015-09-02	509	0
K122438	HAMILTON-MR1	Hamilton Medical AG	2013-11-20	467	1
K131774	HAMILTON-G5	Hamilton Medical AG	2013-10-09	114	4
K123637	HAMILTON-C3	Hamilton Medical AG	2012-12-21	25	0
K121225	HAMILTON-C2	Hamilton Medical AG	2012-11-16	207	2
K120574	HAMILTON-C1	Hamilton Medical AG	2012-05-30	93	0
K120670	HAMILTON-T1	Hamilton Medical AG	2012-04-03	29	1
K112006	HAMILTON-TC1	Hamilton Medical AG	2012-02-09	211	0
K103803	HAMILTON-G5	Hamilton Medical AG	2011-11-23	330	4
K102775	HAMILTON-C2	Hamilton Medical AG	2011-01-21	119	0
K092148	HAMILTON-C2	Hamilton Medical AG	2010-03-04	232	0
K090468	HAMILTON-C2	Hamilton Medical AG	2009-06-15	112	0
K081521	MODIFICATION TO HAMILTON-G5	Hamilton Medical AG	2008-09-25	118	2
K080181	MODIFICATION TO GALILEO GOLD	Hamilton Medical AG	2008-06-24	152	0
K070513	HAMILTON-G5	Hamilton Medical AG	2007-11-26	277	1
K071194	RAPHAEL COLOR ASV VENTILATOR	Hamilton Medical AG	2007-10-18	171	0
K061090	GALILEO GOLD ASV	Hamilton Medical AG	2006-07-17	90	0
K052863	RAPHAEL COLOR	Hamilton Medical AG	2006-01-06	87	3
K041781	VENTILAIR II MEDICAL AIR COMPRESSOR	Hamilton Medical AG	2005-03-14	256	0
K022679	RAPHAEL	Hamilton Medical AG	2003-10-22	436	3
K030563	ARABELLA NCPAP MASKS	Hamilton Medical AG	2003-09-09	200	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