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Data / Medical devices / Sweden / Maquet Critical Care AB

Maquet Critical Care AB: FDA-registered device maker in SOLNA Stockholm, Sweden, 22 510(k) clearances

Maquet Critical Care AB is registered with the FDA (registration 8010042) in SOLNA Stockholm, Sweden. It lists 22 device types. The FDA files 22 510(k) clearances under its listings, the newest dated July 6, 2023. 3 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Maquet Critical Care AB
FDA registration number
8010042
FEI number
3002808128
Address
Roentgenvagen 2, SOLNA Stockholm, Sweden, S-17154
Owner or operator
Maquet Critical Care AB (8010042)
Roles
Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed
February 19, 2008
Registered through
2026
Brand names listed
Absorber FLOW-i, Anesthesia mask, Disposable, Anesthesia mask, Reusable, Breathing Bag Anesthesia, Disposable, Breathing Bag Anesthesia, Reusable, Breathing Bag set Anesthesia, Reusable, Breathing circuit, Breathing system and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Carbon-DioxideBSF1Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Manufactureraccessdata.fda.gov
Compressor, Air, PortableBTI2Manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Exporter to the USaccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Exporter to the USaccessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use VentilatorMNT2Manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufactureraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Specification developeraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Exporter to the USaccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Probe, ThermodilutionKRB2Exporter to the USaccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the USaccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 6, 2023K230173Servo-air Lite Ventilator SystemMNTSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
June 16, 2023K220703F&P 950 Respiratory HumidifierBTTSubstantially EquivalentFisher & Paykel Healthcareaccessdata.fda.gov
April 20, 2021K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1CBKSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
June 18, 2020K192604Servo-air 4.0 Ventilator SystemCBKSubstantially EquivalentMaquet Critica Care ABaccessdata.fda.gov
March 18, 2020K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
March 19, 2019K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBKSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
March 29, 2017K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40BSZSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
March 2, 2017K153688Edi Catheter ENFitPIFSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
December 21, 2015K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemCBKSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
December 11, 2015K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cmKNTSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
June 20, 2014K123149SERVO-I VENTILATOR SYSTEMCBKSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
March 20, 2014K133958FLOW-I ANESTHESIA SYSTEM C20, C30 & C40BSZSubstantially EquivalentMaquet Critical Care ABaccessdata.fda.gov
August 2, 2012K122121PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEDXGSubstantially EquivalentPulsion Medical Systems SEaccessdata.fda.gov
September 22, 2011K112448PULSIOFLEXDXGSubstantially EquivalentPulsion Medical Systems, Inc.accessdata.fda.gov
June 18, 2010K091786PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)DXGSubstantially EquivalentPulsion Medical Systems AGaccessdata.fda.gov
October 18, 2007K072735PULSION PICCO-2, MODEL 8500DXGSubstantially EquivalentPulsion Medical Systems AGaccessdata.fda.gov
September 19, 2007K072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESKRBSubstantially EquivalentPulsion Medical Systems AGaccessdata.fda.gov
May 7, 2007K070642AERONEB PROFESSIONAL NEBULIZER SYSTEMCAFSubstantially EquivalentAerogen (Ireland), Ltd.accessdata.fda.gov
April 26, 2004K030071SERVO GUARD, MODEL 64 81 290 EH88ECAHSubstantially EquivalentMaquet, Inc.accessdata.fda.gov
April 13, 2004K033710MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHUBTTSubstantially EquivalentFisher & Paykel Healthcare, Ltd.accessdata.fda.gov
May 23, 2002K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046KRBSubstantially EquivalentPulsion Medical Systems AGaccessdata.fda.gov
March 25, 1985K842352PRESSURE MONITORING KITDRSSubstantially EquivalentUtah Medical Products, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 30, 202699439Class IIOngoingGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility useMaquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing.accessdata.fda.gov
June 24, 202699359Class IIOngoingFlow 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 6887900Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.accessdata.fda.gov
May 30, 202597032Class IOngoingServo-u Ventilator System. Model Number: 6688600.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.