# K980553: Narkomed 6000 Model Number NM6000

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Aug 4, 1998 after 173 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 K901713 (1990). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
4 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901713: Narkomed 4 Anesthesia System, Draeger Medical, Inc. (1990) Summary page 1.

## Most influential descendants
- K993826: Narkomed 6000 (2000), 16 descendants of its own
- K033498: Narkomed 6400, Model NM6400 (2004), 15 descendants of its own
- K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System (2004), 14 descendants of its own
- K983635: Julian Anesthesia Workstation, Model # Julian (1999), 11 descendants of its own
- K042607: Primus US (2004), 10 descendants of its own

## Indications for use
The NM6000 is indicated as a continuous flow anesthesia system. The NM6000 may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of 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/K980553
Methodology: https://510kreport.com/methodology