# Maquet Critical Care AB

- Location (FDA's records): Solna, SE
- FDA decisions: 20 (2004–2026): 20 510(k) clearances
- Product codes: CBK (9), BSZ (5), KNT (2), PIF (2), MNT (1), CAH (1)
- 510(k) review time since 2016: median 385 days, against 239 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 47 (16 its own); citations of its devices by later devices: 33 (16 its own)
- Recalls linked to its devices: 37 (16 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Datex-Ohmeda, Inc.: 4 (https://510kreport.com/company/datex-ohmeda)
- Bio-Med Devices, Inc.: 2 (https://510kreport.com/company/bio-med-devices)
- Biosearch Medical Products, Inc.: 2 (https://510kreport.com/company/biosearch-medical-products)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Bird Products Corp.: 2 (https://510kreport.com/company/bird-products)
- Arzco Medical Electronics, Inc.: 2 (https://510kreport.com/company/arzco-medical-electronics)
- Drager Medizintechnik GmbH: 1 (https://510kreport.com/company/drager-medizintechnik)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)

## Firms that cite its devices most
- Hamilton Medical AG: 6 (https://510kreport.com/company/hamilton-medical)
- Datex-Ohmeda, Inc.: 3 (https://510kreport.com/company/datex-ohmeda)
- Datex-Ohmeda Inc., A Division of Instrumentarium C: 2 (https://510kreport.com/company/datex-ohmeda-a-division-of-instrumentarium-c)
- Linde Gas Therapeutics: 1 (https://510kreport.com/company/linde-gas-therapeutics)
- Maquet Critica Care AB: 1 (https://510kreport.com/company/maquet-critica-care)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Newport Medical Instruments, Inc.: 1 (https://510kreport.com/company/newport-medical-instruments)
- Covidien, Formerly Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/covidien-formerly-nellcor-puritan-bennett)

## Its most-cited devices
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), cited by 10
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), cited by 4
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), cited by 4
- K123149: Servo-I Ventilator System (2014), cited by 3
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (2019), cited by 3
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), cited by 2

## Recent decisions
- K253715: Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) (Aug 26, 2026)
- K230173: Servo-air Lite Ventilator System (Jul 6, 2023)
- K201874: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (Apr 20, 2021)
- K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (Mar 18, 2020)
- K182862: Servo Guard (Oct 21, 2019)
- K180098: SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (Mar 19, 2019)
- K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (Mar 29, 2017)
- K153688: Edi Catheter ENFit (Mar 2, 2017)

Source page: https://510kreport.com/company/maquet-critical-care