# K981845: Hawk Anaesthesia Induction Unit

- Pathway: 510(k) (Traditional)
- Applicant: Medical Industrial Equipment
- Decided: Nov 3, 1998 after 161 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 Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents. The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar. The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator’s manual. The Hawk may be safely used with magnetic resonance imaging systems (MRI) as it is MRI compatible. It is recommended that pre-use checks and preparation is done by suitably qualified technicians, and that the device is used only by trained and qualified physicians. The device is used in the induction room, operating room, recovery room or similar surgical environments.

Source page: https://510kreport.com/device/K981845
Methodology: https://510kreport.com/methodology