# K163382: Oxitone 1000

- Pathway: 510(k) (Traditional)
- Applicant: Oxitone Medical, Ltd.
- Decided: May 9, 2017 after 159 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: 4 generations back to K001085 (2000). 4 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112843: Pulse Oximeter, Nonin Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K181006: BB-613 Watch Oximeter (2018), 15 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 descendants of its own

## Indications for use
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO₂) and pulse rate. It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.

Source page: https://510kreport.com/device/K163382
Methodology: https://510kreport.com/methodology