# K141105: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
- Decided: Dec 4, 2014 after 219 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: 3 generations back to K001085 (2000). 3 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130947: Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2013) Summary page 7.

## Most influential descendants
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2023), 1 descendant of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2026), 0 descendants of its own

## Indications for use
The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

Source page: https://510kreport.com/device/K141105
Methodology: https://510kreport.com/methodology