# K233827: OxiWear

- Pathway: 510(k) (Traditional)
- Applicant: Oxiwear, Inc.
- Decided: Aug 28, 2024 after 271 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K931154 (1993). 84 ancestors in all.
No later device cites it as a predicate yet.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso, Nonin Medical, Inc. (2016) Summary page 6.

## Indications for use
The OxiWear system is indicated for non-invasive, spot-checking and/or continuous data collection of adult (22+) and adolescent (12-21) patients who are well or poorly perfused, during motion and non-motion conditions. It is intended for use in hospitals, medical facilities, home healthcare environments, and mobile environments. The recommended application site is the helix of the ear.

Source page: https://510kreport.com/device/K233827
Methodology: https://510kreport.com/methodology