# K031707: SK Med M201 Plus Mixer

- Pathway: 510(k) (Special)
- Applicant: Sk Med
- Decided: Aug 1, 2003 after 60 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure. battery voltage. and output os>-genpercentage.

Source page: https://510kreport.com/device/K031707
Methodology: https://510kreport.com/methodology