# K033498: Narkomed 6400, Model NM6400

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Apr 26, 2004 after 173 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K901713 (1990). 6 ancestors in all.
15 later devices descend from it; 2 cite it directly.
4 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993826: Narkomed 6000, Draeger Medical, Inc. (2000) Summary page 1.
- K921669: Marquette SL Series Transport Remote Acquisition, Marquette Electronics, Inc. (1993) Summary page 1.
- K993757: SOLAR 7/8000, General Electric Medical Systems Information Techn (2000) Summary page 1.

## Most influential descendants
- K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System (2004), 14 descendants of its own
- K042607: Primus US (2004), 10 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own

## Recalls of this device
- Sep 15, 2004 · Not classified · Z-0192-05: rotating knob of the rotary style APL valve can become separated from the assembly.

## Indications for use
The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of, oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K033498
Methodology: https://510kreport.com/methodology