Chrysalis Intelligence · Sponsors · Maquet Critical Care AB

Maquet Critical Care AB

Solna, SE · 3 510(k) clearances · 4 recalls (3 Class I)

Total clearances
3
2020-03-18 → 2023-07-06
Last 12 months
0
Product codes
3
Most recent
2023-07-06
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MNT Sv70 Ventilator Class II Anesthesiology 1 2023-07-06
CBK 1 2021-04-20
BSZ Gas-Machine, Anesthesia Class II Anesthesiology 1 2020-03-18
Safety

Recalls (4)

Class I (serious)
3
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2026-06-24
DateSeverityStatusRecall # ProductCodeReason
2026-06-24 Class II Ongoing 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 68… Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient rec…
2025-05-30 Class I Ongoing 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 …
2025-05-30 Class I Ongoing 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 …
2025-05-30 Class I Ongoing 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 …
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2023-07-06 K230173 Servo-air Lite Ventilator System MNT Class II Anesthesiology
2021-04-20 K201874 Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 CBK
2020-03-18 K191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System BSZ Class II Anesthesiology