# K003251: Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690

- Pathway: 510(k) (Traditional)
- Applicant: Blease Medical Equipment, Ltd.
- Decided: May 23, 2001 after 218 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041430: Blease Sirius Anesthesia System, Models 3000 and 2000 (2004), 4 descendants of its own
- 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

## Recalls of this device
- Oct 17, 2013 · Class I · Z-0352-2014: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware i
- 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 
- Nov 2, 2012 · Class II · Z-0565-2013: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The m

Source page: https://510kreport.com/device/K003251
Methodology: https://510kreport.com/methodology