# K982132: Blease 6200 Anaesthesia Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Blease Medical Equipment, Ltd.
- Decided: Apr 15, 1999 after 302 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- Jul 31, 2002 · Not classified · Z-0165-04: Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.

## Indications for use
The Blease 6200 anaesthesia ventilator is an advanced microprocessor controlled, pneumatically driven ventilator (controller) specifically designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. It is designed for use with a circle type absorber and is ideally suited to both low-flow and high-flow applications. The ventilator may also be used with either a Bain-type coaxial circuit or a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary. The device is intended for use only by a suitably qualified physician.

Source page: https://510kreport.com/device/K982132
Methodology: https://510kreport.com/methodology