# K051629: Bleas Esiriuc Anaesthsia System, Models 3000, 2000

- Pathway: 510(k) (Special)
- Applicant: Blease USA, Inc.
- Decided: Sep 23, 2005 after 95 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: 2 generations back to K982132 (1999). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041430: Blease Sirius Anesthesia System, Models 3000 and 2000, Blease Medical Equipment, Ltd. (2004) Summary page 1.

## Most influential descendants
- K101850: Spacelabs Bleasesirius Anesthesia Workstation (2011), 2 descendants of its own
- K112729: BLEASE700/900 Series Ventilators (2012), 0 descendants of its own
- K113051: Spacelabs Arkon Anesthesia Workstation (2012), 0 descendants of its own

## Recalls of this device
- Jun 24, 2010 · Not classified · Z-2113-2010: Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.
- Mar 26, 2010 · Not classified · Z-1408-2010: Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the va
- Jun 25, 2009 · Not classified · Z-0813-2011: Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems.

## Indications for use
The Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

Source page: https://510kreport.com/device/K051629
Methodology: https://510kreport.com/methodology