# K213948: OxyMinder

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med Devices, Inc.
- Decided: Mar 17, 2022 after 90 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911344 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153659: MaxO2ME, Maxtec, LLC (2016) Summary page 4.

## Indications for use
The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.

Source page: https://510kreport.com/device/K213948
Methodology: https://510kreport.com/methodology