# K022031: Narkomed Mri-2 Anesthesia System, Model NM-Mri-2

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Aug 29, 2002 after 69 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: 1 generation back to K003579 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003579: Narkomed Mri-2, Model NM-Mri-2, Draeger Medical, Inc. (2001) Summary page 1.

## Indications for use
The NM-MRI-2 can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The NM-MRI-2 is intended for use with Drager-Vapor0 vaporizers. The NM-MRI-2 can be used in MRI scanner rooms with magnet strengths up to 3.0 tesla without distance limitations.

Source page: https://510kreport.com/device/K022031
Methodology: https://510kreport.com/methodology