# K163135: Finger Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Fitfaith Technology Co.,Ltd
- Decided: Sep 19, 2017 after 315 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: 6 generations back to K001085 (2000). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140582: Fingertip Pulse Oximeter, Shenzhen Jumper Medical Equipment Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K203854: Pulse Oximeter (2021), 1 descendant of its own
- K213430: Fingertip Pulse Oximeter (2022), 0 descendants of its own
- K213984: Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) (2022), 0 descendants of its own
- K182401: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology (IRT) Thermometer probe, B.O.L.T Pulse Oximeter (SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K163135
Methodology: https://510kreport.com/methodology