ClearanceBrief
510(k) K201874 ยท CBK Ventilator, Continuous, Facility Use

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

ApplicantMaquet Critical Care AB, Solna, SE
DecisionSubstantially Equivalent, Apr 20, 2021
ReceivedJul 7, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201874

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Maquet Critical Care AB
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
Open, Classified		 CBKNone listed
Jun 27, 2025Maquet Critical Care AB
Servo-u Ventilator System. Model Number: 6688600.
Open, Classified		 CBKNone listed
Jun 27, 2025Maquet Critical Care AB
Servo-n Ventilator System. Model Number: 6694800.
Open, Classified		 CBKNone listed
Jun 27, 2025Maquet Critical Care AB
Servo-u MR Ventilator System. Model Number: 6888800.
Open, Classified		 CBKNone listed
Jul 20, 2022Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 688200
Open, Classified		 CBKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.