# K112729: BLEASE700/900 Series Ventilators

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare
- Decided: Jun 11, 2012 after 265 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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: 4 generations back to K982132 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101850: Spacelabs Bleasesirius Anesthesia Workstation, Spacelabs Healthcare, Ltd. (2011) Summary page 1.

## Recalls of this device
- Mar 5, 2015 · Class II · Z-1458-2015: Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low c

## Indications for use
The Blease 900 Series Ventilators are advanced, microprocessor-controlled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

Source page: https://510kreport.com/device/K112729
Methodology: https://510kreport.com/methodology