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

Maquet Critical Care AB · Predicate Candidate Screening

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

172 daysmedian FDA review time

435 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K230173	Servo-air Lite Ventilator System	Maquet Critical Care AB	2023-07-06	167	0
K201874	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1	Maquet Critical Care AB	2021-04-20	287	4
K191027	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e A	Maquet Critical Care AB	2020-03-18	335	9
K182862	Servo Guard	Maquet Critical Care AB	2019-10-21	375	0
K180098	SERVO-U Ventilator System version 2.1; SERVO-n Ventilator Sy	Maquet Critical Care AB	2019-03-19	427	0
K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30,	Maquet Critical Care AB	2017-03-29	385	0
K153688	Edi Catheter ENFit	Maquet Critical Care AB	2017-03-02	435	0
K151814	SERVO-U Ventilator System, SERVO-n Ventilator System	Maquet Critical Care AB	2015-12-21	168	0
K153461	Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Cathete	Maquet Critical Care AB	2015-12-11	10	0
K123149	SERVO-I VENTILATOR SYSTEM	Maquet Critical Care AB	2014-06-20	623	1
K133958	FLOW-I ANESTHESIA SYSTEM C20, C30 & C40	Maquet Critical Care AB	2014-03-20	86	8
K112114	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40	Maquet Critical Care AB	2012-01-13	172	1
K102182	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77	Maquet Critical Care AB	2011-05-09	279	0
K101199	GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR	Maquet Critical Care AB	2010-08-27	120	0
K073179	SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTI	Maquet Critical Care AB	2008-06-09	209	0
K063404	SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800	Maquet Critical Care AB	2007-02-15	98	0
K062793	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTIO	Maquet Critical Care AB	2007-02-07	142	0
K041223	MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E	Maquet Critical Care AB	2004-07-29	80	8
K040221	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Maquet Critical Care AB	2004-02-20	18	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