# K153021: Fingertip Pulse Oximeter A310

- Pathway: 510(k) (Traditional)
- Applicant: Amemo, Inc.
- Decided: Nov 22, 2016 after 404 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.
17 later devices descend from it; 2 cite it directly.
0 of 22 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 4.

## Most influential descendants
- K173123: Pulse Oximeter (2018), 11 descendants of its own
- K191430: Pulse Oximeter (2019), 7 descendants of its own
- K190869: Pulse Oximeter (2019), 4 descendants of its own
- K212665: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) (2022), 1 descendant of its own
- K202173: Pulse Oximeter (2020), 1 descendant of its own

## Indications for use
Fingertip Pulse Oximeter A310 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (Sp0O2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

Source page: https://510kreport.com/device/K153021
Methodology: https://510kreport.com/methodology