# K980489: Vapamasta 6

- Pathway: 510(k) (Traditional)
- Applicant: Medical Industrial Equipment
- Decided: Aug 31, 1998 after 203 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- 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 Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus. Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures. The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane. It is recommended by the manufacturer that the device is prepared for use by trained technicians, and that they are used by trained physicians for the purpose for which they are designed and manufactured as described above. It is recommended that suitable agent monitoring should be utilised at all times when these devices are in use. It is recommended that servicing and re-calibration shall be done at intervals prescribed by the manufacturer and performed by fully trained and authorised persons.

Source page: https://510kreport.com/device/K980489
Methodology: https://510kreport.com/methodology