# K123211: A5 Anesthesia Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp., Patient Monitoring Division
- Decided: Feb 14, 2013 after 125 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930017 (1994). 17 ancestors in all.
8 later devices descend from it; 3 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102471: AS3700 Anesthsia Delivery System, Mindray DS USA, Inc. (2011) Summary page 1.
- K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- 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

## Recalls of this device
- Jul 14, 2017 · Class II · Z-0846-2018: 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.

## Indications for use
The A5i Anesthesia Delivery 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 A5 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/K123211
Methodology: https://510kreport.com/methodology