# K253330: A5 Anesthesia System (A5); A7 Anesthesia System (A7)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 25, 2026 after 268 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K902859 (1991). 121 ancestors in all.
No later device cites it as a predicate yet.
10 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201957: A8, A9 Anesthesia System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2021) Summary page 6.

## Indications for use
The 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 Anesthesia System 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/K253330
Methodology: https://510kreport.com/methodology