Company · US

Maquet Critical Care AB

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (1 in 12 months)

5recalls (2 in 12 months)

5recalls that name a 510(k)

Product codes

Code	Device	Records
CBK	Ventilator, Continuous, Facility Use	13
BSZ	Gas-Machine, Anesthesia	6
KNT	Tubes, Gastrointestinal (And Accessories)	2
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	2
CAH	Filter, Bacterial, Breathing-Circuit	1
MNT	Continuous, Minimal Ventilatory Support, Facility Use Ventilator	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 26, 2026	K253715	Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Ed Maquet Critical Care AB, SE	PIF
Jul 6, 2023	K230173	Servo-air Lite Ventilator System Maquet Critical Care AB, SE	MNT
Apr 20, 2021	K201874	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Maquet Critical Care AB, SE	CBK
Mar 18, 2020	K191027	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System Maquet Critical Care AB, SE	BSZ
Oct 21, 2019	K182862	Servo Guard Maquet Critical Care AB, SE	CAH
Mar 19, 2019	K180098	SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 Maquet Critical Care AB, SE	CBK
Mar 29, 2017	K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 Maquet Critical Care AB, SE	BSZ
Mar 2, 2017	K153688	Edi Catheter ENFit Maquet Critical Care AB, SE	PIF
Dec 21, 2015	K151814	SERVO-U Ventilator System, SERVO-n Ventilator System Maquet Critical Care AB, SE	CBK
Dec 11, 2015	K153461	Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm Maquet Critical Care AB, SE	KNT
Jun 20, 2014	K123149	SERVO-I VENTILATOR SYSTEM Maquet Critical Care AB	CBK
Mar 20, 2014	K133958	FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 Maquet Critical Care AB	BSZ
Jan 13, 2012	K112114	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 Maquet Critical Care AB	BSZ
May 9, 2011	K102182	MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 Maquet Critical Care AB	BSZ
Aug 27, 2010	K101199	GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, Maquet Critical Care AB	KNT
Jun 9, 2008	K073179	SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 Maquet Critical Care AB	CBK
Feb 15, 2007	K063404	SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 Maquet Critical Care AB	CBK
Feb 7, 2007	K062793	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION Maquet Critical Care AB	CBK
Jul 29, 2004	K041223	MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB	CBK
Feb 20, 2004	K040221	SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB	CBK

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Aug 14, 2026	Maquet Critical Care AB GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use Open, Classified	CBK	K201874
Aug 3, 2026	Maquet Critical Care AB Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900 Open, Classified	BSZ	K191027
Jun 27, 2025	Maquet Critical Care AB Servo-u MR Ventilator System. Model Number: 6888800. Open, Classified	CBK	K201874
Jun 27, 2025	Maquet Critical Care AB Servo-n Ventilator System. Model Number: 6694800. Open, Classified	CBK	K201874
Jun 27, 2025	Maquet Critical Care AB Servo-u Ventilator System. Model Number: 6688600. Open, Classified	CBK	K201874

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