# K012446: Office Based Anesthesia Machine Mri, Model Oba-1 Mri

- Pathway: 510(k) (Special)
- Applicant: Charles A. Smith
- Decided: Oct 3, 2001 after 63 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
Longest line of descent: 3 generations back to K930351 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000859: Office Based Anesthesia Machine, Model Oba-1, Charles A. Smith (2000) Summary page 1.
- K972848: Narkomed Mri Anesthesia System, Draeger Medical, Inc. (1997) Summary page 1.

## Indications for use
The Office Based Anesthesia Unit - OBA-1™ MRI is intended for administration of general inhalation anesthesia using mixtures of oxygen, air and volatile anesthetics, and for providing breathing gas and for either spontaneous ventilation or controlled ventilation of patient lungs. The OBA-1™ MRI can be used in MRI scanner rooms with shielded or unshielded magnets up to 1.5 tesla.

Source page: https://510kreport.com/device/K012446
Methodology: https://510kreport.com/methodology