# K130947: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Oct 3, 2013 after 182 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: 2 generations back to K001085 (2000). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051107: Onyx II Finger Pulse Oximeter, Model 9550, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K141105: Pulse Oximeter (2014), 8 descendants of its own
- 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

## Indications for use
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).

Source page: https://510kreport.com/device/K130947
Methodology: https://510kreport.com/methodology