# K971425: Narkomed M Anesthesia System (M)

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Sep 10, 1997 after 146 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: 2 generations back to K930351 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963994: Narkomed GS Anesthesia System, Draeger Medical, Inc. (1997) Summary page 1.

## Indications for use
The Narkomed M (NM M) is a continuos flow anesthesia system. The NM M may be used for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of oxygen, air, and/or nitrous oxide and anesthetic vapor. It is capable of monitoring oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K971425
Methodology: https://510kreport.com/methodology