# K121697: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Oct 15, 2012 after 130 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093757: MD300C1 Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K131111: Ihealth Fingertip Pulse Oximeter (2013), 0 descendants of its own

## Indications for use
The APO-8284 Fingertip Pulse Oximeter is a non-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). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K121697
Methodology: https://510kreport.com/methodology