# K221979: Pulse Oximeter (Model C101A2, C101B1, C101A3)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
- Decided: Oct 16, 2022 after 103 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173123: Pulse Oximeter, Shenzhen Imdk Medical Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

Source page: https://510kreport.com/device/K221979
Methodology: https://510kreport.com/methodology