Maquet Critical Care AB
SOLNA Stockholm, SE
MAQUET CRITICAL CARE AB appears in FDA device records in SOLNA Stockholm, SE. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Maquet Critical Care AB between 2004 and 2023. The busiest year on record is 2004, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230173 | Servo-air Lite Ventilator System | MNT | Substantially Equivalent | |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | CBK | Substantially Equivalent | |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | BSZ | Substantially Equivalent | |
| K182862 | Servo Guard | CAH | Substantially Equivalent | |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | CBK | Substantially Equivalent | |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | BSZ | Substantially Equivalent | |
| K153688 | Edi Catheter ENFit | PIF | Substantially Equivalent | |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | CBK | Substantially Equivalent | |
| 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 | KNT | Substantially Equivalent | |
| K123149 | SERVO-I VENTILATOR SYSTEM | CBK | Substantially Equivalent | |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | BSZ | Substantially Equivalent | |
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 | BSZ | Substantially Equivalent | |
| K102182 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 | BSZ | Substantially Equivalent | |
| K101199 | GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, | KNT | Substantially Equivalent | |
| K073179 | SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 | CBK | Substantially Equivalent | |
| K063404 | SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 | CBK | Substantially Equivalent | |
| K062793 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION | CBK | Substantially Equivalent | |
| K041223 | MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E | CBK | Substantially Equivalent | |
| K040221 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010042 | 3002808128 | MAQUET CRITICAL CARE AB | ROENTGENVAGEN 2, SOLNA Stockholm S-17154 SE | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BSFAbsorber, Carbon-Dioxide
- BTCBag, Reservoir
- CATCannula, Nasal, Oxygen
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BTICompressor, Air, Portable
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BYDCondenser, Heat And Moisture (Artificial Nose)
- MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- BSZGas-Machine, Anesthesia
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BSJMask, Gas, Anesthetic
- CAFNebulizer (Direct Patient Interface)
- KRBProbe, Thermodilution
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BTKStrap, Head, Gas Mask
- DRSTransducer, Blood-Pressure, Extravascular
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2963-2026 | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use | Maquet 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. | Class II | Open, Classified | |
| Z-2860-2026 | 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 | Events 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. | Class II | Open, Classified | |
| Z-2015-2025 | Servo-u MR Ventilator System. Model Number: 6888800. | 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. | Class I | Open, Classified | |
| Z-2014-2025 | Servo-n Ventilator System. Model Number: 6694800. | 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. | Class I | Open, Classified | |
| Z-2013-2025 | Servo-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. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain