# K101850: Spacelabs Bleasesirius Anesthesia Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Mar 2, 2011 after 244 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982132 (1999). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K051629: Bleas Esiriuc Anaesthsia System, Models 3000, 2000, Blease USA, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- Jan 15, 2013 · Class I · Z-0968-2013: A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being 

## Indications for use
The Spacelabs BleaseSirius Anesthesia Workstation is 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 anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

Source page: https://510kreport.com/device/K101850
Methodology: https://510kreport.com/methodology