510(k) Report

FDA applicant

Maquet Critical Care AB

Solna, SE20 decisions2004–202637 recalls

FDA records 20 decisions for Maquet Critical Care AB (Solna, SE) from 2004 to 2026: 20 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BSZ (Gas-Machine, Anesthesia). Since 2016 its 510(k)s took a median of 385 days from receipt to decision, against 239 for FDA’s reviews in the same codes and years. Its devices cite 47 predicates, 16 of them its own earlier devices. 37 recalls are linked to its devices, 16 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Maquet Critical Care AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 22008: 12010: 12011: 12012: 12014: 22015: 22017: 22019: 22020: 12021: 12023: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2026

2008: 22011: 52012: 1, 1 Class I2013: 1, 1 Class I2015: 4, 2 Class I2019: 12020: 12021: 2, 1 Class I2022: 7, 6 Class I2023: 52024: 1, 1 Class I2025: 4, 4 Class I2026 (partial year): 2
2007high 7 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Maquet Critical Care AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maquet Critical Care AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use9decisions
  • BSZGas-Machine, Anesthesia5decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • PIFGastrointestinal Tubes With Enteral Specific Connectors2decisions
  • MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator1decision
  • CAHFilter, Bacterial, Breathing-Circuit1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 385 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 239 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 47 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 16 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 200410cite it
  • K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 20074cite it
  • K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 20084cite it
  • K123149Servo-I Ventilator SystemMaquet Critical Care AB · 20143cite it
  • K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB · 20193cite it
  • K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 20042cite it

What has FDA decided for it lately?

  • K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm…Maquet Critical Care AB · 2026
  • K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB · 2023
  • K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB · 20214 Class I recalls
  • K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 20208 Class I recalls
  • K182862Servo GuardMaquet Critical Care AB · 2019
  • K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB · 2019
  • K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB · 2017
  • K153688Edi Catheter ENFitMaquet Critical Care AB · 20171 recall

All 20 as Maquet Critical Care AB →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K201874GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous…Jun 30, 2026Class II
  • K191027Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i…Jun 24, 2026Class II
  • K201874Servo-n Ventilator System. Model Number: 6694800.May 30, 2025Class I
  • K201874Servo-u MR Ventilator System. Model Number: 6888800.May 30, 2025Class I
  • K201874Servo-u Ventilator System. Model Number: 6688600.May 30, 2025Class I
  • K191027Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i…Jan 15, 2025Class I

Other applicant names beginning “Maquet”

FDA records each applicant name separately; these may or may not be the same firm.

Maquet Cardiopulmonary, AG 44Maquet Cardiovascular, LLC 15Maquet GmbH 8Maquet Critica Care AB 1Maquet GmbH (A Getinge Group Company) 1