# K131111: Ihealth Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Sep 11, 2013 after 145 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: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121697: Fingertip Pulse Oximeter, Andon Health Co, Ltd. (2012) Summary page 1.

## Indications for use
The PO3M Wireless Pulse Oximeter is a nan-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc).

Source page: https://510kreport.com/device/K131111
Methodology: https://510kreport.com/methodology