# K151954: A7 Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 27, 2015 after 104 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 116 ancestors in all.
4 later devices descend from it; 1 cites it directly.
10 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142552: A7 Anesthesia System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 4.
- K042607: Primus US, Draeger Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- K171292: A7 Anesthesia System (2018), 3 descendants of its own
- K201957: A8, A9 Anesthesia System (2021), 1 descendant of its own
- K253330: A5 Anesthesia System (A5); A7 Anesthesia System (A7) (2026), 0 descendants of its own
- K190011: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (2019), 0 descendants of its own

## Recalls of this device
- Jul 14, 2017 · Class II · Z-0847-2018: A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
- Aug 4, 2016 · Class II · Z-2692-2016: Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stai
- Jun 15, 2016 · Class II · Z-2689-2016: Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

## Indications for use
The A7 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 A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

Source page: https://510kreport.com/device/K151954
Methodology: https://510kreport.com/methodology