# K982137: Blease Frontline Genius Range Anaesthesia Machine

- Pathway: 510(k) (Traditional)
- Applicant: Blease Medical Equipment, Ltd.
- Decided: Apr 9, 1999 after 296 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Blease Frontline Genius Range, Anaesthesia Machines are intended for use in the hospital environment and locations not requiring portability. 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 a 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/K982137
Methodology: https://510kreport.com/methodology