# K201957: A8, A9 Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 26, 2021 after 255 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K902859 (1991). 120 ancestors in all.
1 later device descends from it; 1 cites it directly.
10 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171292: A7 Anesthesia System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 5.
- K192972: Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K253330: A5 Anesthesia System (A5); A7 Anesthesia System (A7) (2026), 0 descendants of its own

## Recalls of this device
- Oct 20, 2025 · Class II · Z-0720-2026: Potential for anesthesia leakage.
- Oct 20, 2025 · Class II · Z-0721-2026: Potential for anesthesia leakage.
- Jul 22, 2024 · Class II · Z-2949-2024: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Ane
- Jul 22, 2024 · Class II · Z-2951-2024: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Ane
- Jul 22, 2024 · Class II · Z-2950-2024: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Ane
- Jul 22, 2024 · Class II · Z-2952-2024: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Ane

## Indications for use
The A8, A9 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation. The A8, A9 is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only.

Source page: https://510kreport.com/device/K201957
Methodology: https://510kreport.com/methodology