FLOW-I ANESTHESIA SYSTEM C20, C30 & C40— 510(k) K133958
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K133958 for FLOW-I ANESTHESIA SYSTEM C20, C30 & C40, Substantially Equivalent on 2014-03-20. Applicant: Maquet Critical Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Wayne, NJ, US
Recent devices under product code BSZ
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view all- K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more
- K230173 — Servo-air Lite Ventilator System
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- K182862 — Servo Guard
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133958
K-number listed on FDA's recall record- Z-0987-2024 — Flow-i C20 Anesthesia System, model 6677200
- Z-0988-2024 — Flow-i C30 Anesthesia System, model 6677300
- Z-0989-2024 — Flow-i C40 Anesthesia System, model 6677400
- Z-0990-2024 — Flow-c Anesthesia System, model 6887700
- Z-0991-2024 — Flow-e Anesthesia System, model 6887900
- Z-0804-2016 — Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
- Z-1706-2015 — FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
- Z-2083-2015 — The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133958.
Data sourced from openFDA. This site is unofficial and independent of the FDA.