# K041430: Blease Sirius Anesthesia System, Models 3000 and 2000

- Pathway: 510(k) (Special)
- Applicant: Blease Medical Equipment, Ltd.
- Decided: Oct 7, 2004 after 132 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: 1 generation back to K982132 (1999). 2 ancestors in all.
4 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)
- K003251: Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690, Blease Medical Equipment, Ltd. (2001) Summary page 1.
- K982132: Blease 6200 Anaesthesia Ventilator, Blease Medical Equipment, Ltd. (1999) Summary page 1.

## Most influential descendants
- K051629: Bleas Esiriuc Anaesthsia System, Models 3000, 2000 (2005), 3 descendants of its own
- 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

## Indications for use
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 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/K041430
Methodology: https://510kreport.com/methodology