# K974193: Narkomed Ultrasonic Flow Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Jan 28, 1998 after 82 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 K851620 (1985). 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)
- K851620: Spiromed 2, Draeger Medical, Inc. (1985) Summary page 1.

## Indications for use
The Narkomed Ultrasonic Flow Sensor is indicated for measuring the respiratory flow rate of gas through the patient breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K974193
Methodology: https://510kreport.com/methodology