# K031860: SK Med ME202 Monitoring Mixer

- Pathway: 510(k) (Traditional)
- Applicant: Sk Med
- Decided: Jan 21, 2004 after 219 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051192: Praxair Medical Air Mixer (2005), 0 descendants of its own

## Indications for use
The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (I to 12 LPM). The device is a prescription device and is intended for use within the hospital or institutional environment.

Source page: https://510kreport.com/device/K031860
Methodology: https://510kreport.com/methodology